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BTIG Starts Eiger BioPharma (EIGR) at Buy
July 14, 2017 7:31 AM EDT
BTIG initiates coverage on Eiger BioPharma (NASDAQ: EIGR) with a Buy rating and a price target of $32.00.Analyst Robert Hazlett
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Consensus Ratings for Eiger BioPharmaceuticals (NASDAQ:EIGR) (How are Consensus Ratings Calculated?)
Ratings Breakdown: 5 Buy Ratings
Consensus Rating: Buy (Score: 3.00)
Consensus Price Target: $32.75 (339.60% upside)
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https://www.marketbeat.com/stocks/NASDAQ/EIGR/
EIGR
Eiger Announces Results Demonstrating Benefit of Ubenimex and Leukotriene B4 (LTB4) Modulation in Experimental Lymphedema
- Data Supports Ongoing Phase 2 ULTRA Study of Ubenimex in Lymphedema
PALO ALTO, Calif., May 17, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc., (NASDAQ:EIGR) today announced publication in Science Translational Medicine (STM) the results of extensive preclinical studies of ubenimex in which modulation of the inflammatory mediator, leukotriene B4 (LTB4), improved experimental lymphedema. Targeted reduction of LTB4 with ubenimex reversed edema, improved lymphatic function and restored lymphatic architecture in experimental models of lymphedema. The technology was invented by Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University, which Eiger exclusively licensed in 2015. Based on these findings, Eiger is conducting ULTRA, a multi-center, Phase 2 clinical study of ubenimex in Secondary Lymphedema, currently enrolling at multiple sites in the U.S. and Australia.
Lymphedema is a state of vascular functional insufficiency in which decreased lymphatic clearance of interstitial fluid leads to edema formation, and progressive, debilitating architectural alterations of the skin and supporting tissues. Lymphedema typically manifests itself in an arm or leg, but can affect other parts of the body. Lymphedema often causes long-term physical, psychological, and social problems for patients and significantly impacts quality of life. There is no approved pharmacologic therapy.
"We have demonstrated for the first time that a naturally-occurring inflammatory substance known as LTB4 is elevated in both animal models of lymphedema as well as human patients with lymphedema and that elevated LTB4 is associated with tissue inflammation and impaired lymphatic function," said Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University and Lead Investigator for ULTRA. "Lymphedema is a devastating disorder and an approved pharmacologic therapy is urgently needed. I believe that LTB4 is a promising drug target for the treatment of lymphedema, and I'm pleased to be the lead investigator for the ULTRA clinical study of ubenimex in secondary lymphedema. ULTRA will pave the way for investigating ubenimex in other types of lymphedema, including upper extremity and primary lymphedema."
Tian et al., Sci. Transl. Med. 9, "Leukotriene B4 Antagonism Ameliorates Experimental Lymphedema", May 10, 2017.
About LTB4 and Ubenimex
Leukotriene B4 (LTB4) is a naturally-occurring inflammatory substance known to be elevated in both preclinical models of secondary lymphedema as well as human lymphedema disease. Elevated LTB4 causes inflammation resulting in tissue inflammation and impaired lymphatic function. Targeted pharmacologic inhibition of LTB4 promotes lymphatic repair and reverses lymphedema disease in treated animals.
Ubenimex is a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase (LTA4H), the enzyme responsible for the formation of the pro-inflammatory mediator, LTB4.
Ubenimex is approved in Japan (brand name Bestatin™) as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku. Ubenimex is not approved for any indication in the US or Europe.
About Lymphedema
Lymphedema can be either primary (hereditary) or secondary (caused by another disease or condition). Primary lymphedema is caused by the absence of certain lymph vessels at birth or abnormalities in the lymphatic vessels and can be divided into three forms, depending on age of onset. Secondary lymphedema usually develops as a result of a lymph vessel blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation, or other cancer treatment. Primary lymphedema and secondary lymphedema are large unmet medical needs, as both can be debilitating and negatively impact quality of life. There is no approved pharmacologic treatment for lymphedema.
About the ULTRA Phase 2 Study
ULTRA is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study of ubenimex in patients with secondary lymphedema of the lower limb(s). Up to forty patients may be randomized in a 1:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks. The study will assess clinical, biomarker, histologic and patient-reported outcomes.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the three-month period ended March 31, 2017 and other periodic reports filed with the SEC by Eiger. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-results-demonstrating-benefit-of-ubenimex-and-leukotriene-b4-ltb4-modulation-in-experimental-lymphedema-300459051.html
SOURCE Eiger BioPharmaceuticals, Inc.
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EIGR
Eiger BioPharmaceuticals Reports First Quarter 2017 Financial Results
By PR Newswire, May 12, 2017, 08:00:00 AM EDT
- Five Phase 2 Programs in Four Orphan Indications Progressing
- Multiple Clinical and Regulatory Milestones Expected 2017-2018
PALO ALTO, Calif., May 12, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today financial results for the three months ended March 31, 2017 and provided a business update.
"Building on our achievements in 2016, we have continued to execute on all programs in 2017, and we are anticipating multiple key clinical and regulatory milestones later in 2017 and 2018," said David Cory, President and CEO of Eiger BioPharmaceuticals. "We are especially excited about the recently presented results of our Phase 2 program with lonafarnib in hepatitis delta virus (HDV) infection, and look forward to continued discussions with the FDA and other regulatory agencies regarding next steps in development. In parallel, we have made significant progress advancing the Phase 2 clinical development of exendin 9-39 for post-bariatric hypoglycemia and ubenimex for pulmonary arterial hypertension and lymphedema, underscoring the diversity and therapeutic differentiation of our development pipeline and potential for multiple value-creating events in the coming months."
Key Achievements to Date in 2017
Lonafarnib in HDV
Key results from the Phase 2 LOWR HDV (LOnafarnib With Ritonavir in HDV) program presentations at The International Liver Congress™ in April:
All-Oral LNF 25 mg or 50 mg BID + RTV suppresses HDV-RNA at end of treatment
5 of 14 (36%) HDV-RNA < LOQ (limit of quantitation by qPCR) at Week 24
Addition of PEG IFN to LNF 25 mg BID + RTV results in highest response rates
4 of 5 (80%) HDV-RNA < LOQ at Week 24
3 of 5 (60%) PCR-negative at Week 24
Low-level viremia off-therapy
2 of 2 PCR-negative at 24 weeks post-treatment
60-78% of patients normalized ALT at Week 24
Adverse events (AEs) predominately mild / moderate for LNF 25 / 50 mg regimens
Interferon Lambda in HDV
First patient dosed in international Phase 2 LIMT HDV study (Lambda Interferon Monotherapy Trial in HDV)
U.S. IND filed and approved; opportunity to include clinical sites in the U.S.
Exendin 9-39 in Post-Bariatric Hypoglycemia (PBH)
Lisa Porter, M.D., appointed to lead clinical development
Proprietary liquid formulation developed for subcutaneous injection
Clinical evaluation of liquid formulation in Phase 2 multiple ascending dose (MAD) study and Phase 1 PK study
Ubenimex in Pulmonary Arterial Hypertension (PAH)
Phase 2 LIBERTY study completed enrollment
PAH KOL analyst event - May 10
Ubenimex in Lymphedema
Phase 2 ULTRA international study enrolling
Publication of preclinical results in Science Translational Medicine
Strong Balance Sheet
Expenses on track; cash runway extends through mid-2018
Anticipated Milestones in 2017 and early 2018
Lonafarnib HDV program: FDA meeting planned in the fourth quarter
Lambda in HDV: interim data from LIMT HDV study in the fourth quarter at AASLD
Exendin 9-39 in PBH: completion of MAD study in second quarter 2017 with data to be presented at ADA meeting in June 2017, completion of PK study with novel liquid formulation in the third quarter, and initiation of Phase 2 - 28-day study in the fourth quarter of 2017 with data in the first half of 2018
Ubenimex in PAH: Phase 2 LIBERTY data anticipated in first quarter 2018 at JPM
Ubenimex in Lymphedema: complete ULTRA enrollment in fourth quarter 2017; data anticipated in second quarter 2018.
First Quarter 2017 Financial Results
Net loss for the first quarter of 2017 was $11.2 million, or $1.34 per share basic and diluted, compared to a net loss of $9.7 million, or $10.42 per share basic and diluted for the first quarter of 2016.
Research and development expenses for the first quarter of 2017 were $7.4 million compared to $4.8 million for the first quarter of 2016, an increase of $2.6 million. The increase was primarily due to a $1.6 million increase in clinical expenditures coupled with a $0.9 million increase in compensation and personnel related expenses due to an increase in headcount.
General and Administrative expenses for the first quarter of 2017 were $3.5 million compared to $3.8 million for the first quarter of 2016, a $0.3 million decrease. The decrease was primarily due to a $1.9 million decrease in legal, consulting, advisory and accounting services incurred related to the Merger in the first quarter 2016. The decrease was partially offset by a $0.9 million increase in stock-based compensation expense.
As of March 31, 2017, Eiger had cash, cash equivalents and short term marketable securities of $49.0 million, compared to $59.9 million at December 31, 2016.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward- looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, our ability to timely and successfully achieve, all or any of the anticipated 2017 and 2018 milestones, whether or not pegylated interferon lambda or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger's future operations and drug development portfolio, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors:
Jim Welch, Eiger BioPharmaceuticals, 650-279-9845, jwelch@eigerbio.com
Eiger BioPharmaceuticals Inc.
Selected Statements of Operations Financial Data
(in thousands, except share and per share amounts)
(unaudited)
(Details omitted)
http://www.nasdaq.com/press-release/eiger-biopharmaceuticals-reports-first-quarter-2017-financial-results-20170512-00331
EIGR
Eiger Announces U.S. IND Filing of Pegylated Interferon Lambda for Hepatitis Delta Virus Infection
PALO ALTO, Calif., May 3, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that the U.S. IND has been filed for Pegylated Interferon Lambda in the treatment of hepatitis delta virus (HDV) infection. U.S. sites are planned for the ongoing Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a ("Lambda") as a potential treatment for chronic hepatitis D virus (HDV) infection.
Eiger BioPharmaceuticals (PRNewsFoto/Eiger BioPharmaceuticals, Inc.)
"Filing the U.S. IND for Lambda in the treatment of HDV is a strategic imperative for Eiger," said Shelly Xiong, PhD, RAC, Senior Vice President of Regulatory Affairs at Eiger. "This filing should facilitate discussions with the agency regarding potential Lambda development and registration pathways for HDV as well as expanding the program to U.S. investigators and U.S. patients."
"Over recent years, patients with chronic hepatitis B and hepatitis C have benefited from huge advances in antiviral therapy for both diseases. Unfortunately HDV remains a large unmet medical need because of the lack of any effective therapy for this most aggressive form of viral hepatitis. In many countries, HDV presents a real public health challenge," said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Development at Eiger. "We look forward to expanding our HDV development program to include Lambda monotherapy and potential combinations, including lonafarnib."
About the LIMT HDV Phase 2 Study
LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in approximately 30-40 patients with chronic HDV. End of treatment will be followed by a treatment-free 24-week observation period. The primary objective of the phase 2 study is to evaluate the safety, tolerability, and efficacy of treatment with two dose levels of Lambda monotherapy in patients with chronic HDV infection. All patients will also be administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study. LIMT HDV is an international study currently enrolling at sites in New Zealand, Israel and Pakistan.
About Pegylated Interferon Lambda 1a
Pegylated interferon lambda 1a ("Lambda") is a well-characterized, late-stage, first in class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa. These type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce the off-target effects associated with other IFNs and improve the tolerability of Lambda. Although Lambda does not use the IFN alfa receptor, signaling through either the IFN lambda or IFN alfa receptor complexes results in the activation of the same Jak-STAT signal transduction cascade.
Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb in April 2016. Lambda has been administered in HBV / HCV clinical trials involving over 3,000 subjects. Lambda has not been approved for any indication.
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-us-ind-filing-of-pegylated-interferon-lambda-for-hepatitis-delta-virus-infection-300450390.html
SOURCE Eiger BioPharmaceuticals, Inc.
Copyright 2017 PR Newswire
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EIGR
Eiger Announces Additional Phase 2 Clinical Trial Results for Lonafarnib at The International Liver Congress™ 2017
By PR Newswire, April 21, 2017, 08:00:00 AM EDT
PALO ALTO, Calif., April 21, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc., (NASDAQ:EIGR) today announced additional supportive and encouraging lonafarnib (LNF) data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented at The International Liver Congress™ 2017, in Amsterdam, Netherlands. After 24 weeks of treatment, all-oral lonafarnib-based regimens (LNF 25 mg or 50 mg BID + Ritonavir, or RTV) suppressed HDV-RNA below the limit of quantitation in 36% of patients, and 60% achieved ALT normalization. The addition of PEG IFN to LNF 25 mg BID + RTV (triple therapy) suppressed HDV-RNA below the limit of quantitation in 80% of patients, and 78% achieved ALT normalization. In patients treated for 48 weeks with triple therapy of PEG IFN + LNF 25 mg BID + RTV, PCR-negativity was achieved in 67% of patients at the end of treatment.
"The LOWR HDV program was designed to identify optimal lonafarnib-based regimens to advance in development for the treatment of HDV, and we're continuing to successfully progress towards our goal," said David Cory, President and CEO of Eiger. "Data presented this week demonstrate multiple encouraging outcomes with lonafarnib-based regimens including viral load decline greater than 2 logs, viral load below the limit of quantitation, PCR-negativity, and ALT normalization. In addition, the finding that anti-HDV activity is enhanced with the addition of pegylated interferon alpha to lonafarnib-based regimens is particularly encouraging. We plan to advance all-oral lonafarnib-based regimens as well as triple therapy to include pegylated interferon lambda as potential treatments for HDV."
Key Results from LOWR Program Presentations:
End of Treatment Results at Week 24 (24 weeks dosing)
All-Oral LNF 25 mg or 50 mg BID + RTV suppresses HDV-RNA at end of treatment (Week 24)
5 of 14 (36%) HDV-RNA < LOQ (Limit of Quantitation by qPCR)
1 of 14 (9%) PCR-negative
4 of 8 (50%) > 2 log decline in patients with high baseline viral load (HDV RNA > 5 log)
Addition of PEG IFN to LNF 25 mg BID + RTV results in the highest response rates (Week 24)
4 of 5 (80%) HDV-RNA < LOQ
3 of 5 (60%) PCR-negative
3 of 4 (75%) > 2 log decline in patients with high baseline viral load (HDV RNA > 5 log)
ALT normalization achieved in LNF 25 mg or 50 mg BID + RTV regimens
60% (all-oral)
78% (with PEG IFN)
Adverse events (AEs) predominantly mild / moderate GI events with LNF treatment
Post-Treatment Follow-Up at Week 48 (24 weeks dosing + 24 weeks post-dosing)
Addition of PEG IFN to LNF 25 mg BID + RTV led to low-level viremia off therapy, with PCR negativity in patients at 24 weeks post-treatment
2 of 2 PCR-negative at 24 weeks post-treatment
End of Treatment Results at Week 48 (48 weeks dosing)
Addition of PEG IFN to LNF 25 mg BID + RTV
2 of 3 (67%) PCR-negative
Additional dosing regimens were also explored in the LOWR program, including QD dosing of LNF + RTV and dose titration with BID dosing of LNF + RTV. Anti-HDV activity was observed in all regimens (LNF 50 mg QD + RTV up to LNF 100 mg BID + RTV) through Week 24 on treatment. HDV viral load returned to baseline in a majority of these patients by Week 24 of post-treatment, suggesting longer-term treatment of all-oral LNF + RTV or triple combination of LNF + RTV + PEG IFN may be necessary to achieve sustained antiviral suppression.
"Hepatitis Delta is the most aggressive form of viral hepatitis, and due to the absence of an approved therapy, HDV infection remains a significant unmet medical need and a public health challenge," said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Development at Eiger. "Each of the lonafarnib presentations given at The International Liver Congress™ 2017 highlight the activity of lonafarnib-based regimens in the treatment of patients with HDV infection. We look forward to discussing next steps with regulatory agencies later this year."
Presentations at The International Liver Congress™ 2017:
Wedemeyer, H. et al; "A Phase 2 Dose-Escalation Study of Lonafarnib Plus Ritonavir in Patients With Chronic Hepatitis D: Final Results from The Lonafarnib With Ritonavir in HDV-4 (LOWR HDV-4) Study"; Abstract #PS-039, Oral Presentation.
Yurdaydin, C. et al; "A Phase 2 Dose-Optimization Study of Lonafarnib with Ritonavir for the Treatment of Chronic Delta Hepatitis—End of Treatment Results from the LOWR HDV-2 Study"; Abstract #GS-008, Oral Presentation.
Koh, C. et al; "Phase 2 study exploring once daily dosing of ritonavir boosted lonafarnib for the treatment of chronic delta hepatitis - end of study results from the LOWR HDV-3 study"; Abstract #LBP-519, Poster Presentation.
Yurdaydin, C. et al; "The Prenylation Inhibitor Lonafarnib (LNF) Can Induce Post-Treatment Viral Clearance in Patients with Chronic Delta Hepatitis (CDH) Resulting in ALT Normalization and Regression of Fibrosis"; Abstract #THU-161, Poster Presentation, Oral ePoster Presentation.
Yurdaydin, C. et al; "Results from Retreatment with Lonafarnib of a Subset of HDV-Infected Patients"; 13th Hepatitis Delta International Network (HDIN) Meeting, Oral Presentation.
LOWR HDV Studies:
The LOWR HDV program was designed to be a multi-center, international Phase 2 program, to identify dosing regimens and durations of lonafarnib (LNF) with ritonavir (RTV) ± pegylated interferon (PEG IFN) to move forward in development for the treatment of hepatitis delta infection (HDV).
LOWR HDV - 2 is a dose-finding study to identify combination regimens of lonafarnib and ritonavir ± PEG IFN a, with efficacy and tolerability for longer term dosing to enable HDV RNA clearance. In this open-label study, 58 HDV-infected patients have been enrolled to date into 10 groups of different doses of lonafarnib in combination with ritonavir ± PEG IFN a for dosing durations of 12 to 48 weeks. Lonafarnib doses range from 25 mg BID to 100 mg BID. LOWR HDV - 2 is closing at Ankara University in Ankara, Turkey.
LOWR HDV - 3 was a double-blinded, randomized, placebo-controlled study designed to evaluate the efficacy and tolerability of once-daily doses of lonafarnib - 50 mg, 75 mg and 100 mg - each combined with ritonavir 100 mg once daily for 12 or 24 weeks. Twenty-one patients with chronic hepatitis delta were randomized into one of six treatment groups. LOWR HDV - 3 was conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, and the study has completed.
LOWR HDV - 4 was an open-label study to evaluate the efficacy and tolerability of dose escalation of lonafarnib combined with ritonavir administered twice daily for dosing durations of 24 weeks. Fifteen patients were initiated at lonafarnib 50 mg and ritonavir 100 mg twice daily, and dose-escalated up to lonafarnib 100 mg twice daily as tolerated. LOWR HDV - 4 was conducted at Hannover Medical School in Hannover, Germany, and the study has completed.
About Sarasar™ (lonafarnib)
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Lonafarnib has been dosed in over 120 HDV-infected patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-additional-phase-2-clinical-trial-results-for-lonafarnib-at-the-international-liver-congress-2017-300443308.html
SOURCE Eiger BioPharmaceuticals, Inc.
_____________________________________________
EIGR
Eiger Announces Industry Veteran Lisa Porter, M.D. to Lead Development of Exendin 9-39 for the Treatment of Post-Bariatric Hypoglycemia
By PR Newswire, April 18, 2017, 08:00:00 AM EDT
- Novel Liquid Formulation of Exendin 9-39 Advancing
PALO ALTO, Calif., April 18, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of therapies for rare diseases, today announced the appointment of Lisa Porter, M.D. to lead the development of exendin 9-39 for the treatment of post-bariatric hypoglycemia (PBH).
"Dr. Porter brings over 15 years of experience in developing medicines for diabetes and metabolic diseases with a singular focus on bringing innovative therapies to patients with high unmet need," said David Cory, President and CEO of Eiger. "As the exendin 9-39 program in PBH matures with nearly 30 patients dosed in the clinic, we prepare to advance a novel liquid formulation of exendin 9-39 and are very excited to welcome Dr. Porter to the team. We have great confidence that she will take exendin 9-39 and the PBH program to the next level."
Dr. Porter was most recently Chief Medical Officer of Dance BioPharm, focused on the development of inhaled insulin products to treat diabetes. Previously, she was Vice President, Medical Development of Amylin Pharmaceuticals where she led the R&D efforts for the Amylin-Lilly Alliance culminating in the approval of the GLP-1 agonist Bydureon (exenatide extended release), the first once weekly treatment for Type 2 diabetes. Earlier, Dr. Porter held positions of increasing leadership at GlaxoSmithKline, where she was responsible for clinical strategy for Avandia (rosiglitazone) for Type 2 diabetes. Dr. Porter earned a B.S. in Biology from William & Mary, an M.D. from Duke University, and completed her fellowship in Endocrinology and Hypertension at Brigham and Women's Hospital.
"Eiger and Stanford have made amazing progress across multiple clinical studies in which exendin 9-39 was shown to prevent and reduce symptoms of hypoglycemia in post-bariatric surgical patients during an oral glucose tolerance test (OGTT), and I'm very encouraged by the results," said Lisa Porter, M.D. "Exendin 9-39 represents the first potential targeted therapy for patients suffering from PBH, a significant unmet medical need. I'm excited to join the team and lead this program moving forward."
Eiger is developing a proprietary, novel liquid formulation of exendin 9-39 which in dog studies has demonstrated a greater than two-fold increase in peak plasma concentrations compared to the original lyophilized powder of exendin 9-39. Development of a liquid formulation of exendin 9-39 represents an opportunity for lower dosing and once on the market, would eliminate the need for patients to dissolve powder in saline, which could be a more convenient product presentation for patients. Eiger is evaluating the new exendin 9-39 liquid formulation in patients in the ongoing MAD study and also in a Phase 1 PK study scheduled for Q2 2017, both of which will inform the next, larger Phase 2 study planned for second half 2017.
About Insulin, GLP-1, and Exendin 9-39
Insulin is the principal physiologic hormone secreted to control high blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including seizures, brain damage, and coma. GLP-1 is a gastrointestinal hormone that is released postprandially from the intestinal L-cells. GLP-1 binds to GLP-1 receptors on the beta cells of the pancreas and increases the release of insulin. In patients with PBH,
GLP-1-mediated insulin secretion is dysfunctionally exaggerated.
Exendin 9-39 is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Exendin 9-39 is being investigated as a novel treatment for PBH. Exendin 9-39 has been granted orphan designation in the European Union by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) and orphan designation in the United States by the FDA for the treatment of hyperinsulinemic hypoglycemia. Both of these broad designations include PBH. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism. Exendin 9-39 has never been approved or commercialized for any indication. The long-term efficacy and safety of subcutaneous (SC) injected exendin 9-39 have not yet been established. More information on exendin 9-39 clinical trials may be found at www.clinicaltrials.gov.
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the United States, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the United States and approximately 25,000 in the European Union. As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing 12 to 18 months following surgery. PBH can occur with a range of severity in post-bariatric surgery patients. Mild to moderate hypoglycemia may be managed largely through dietary carbohydrate restriction, whereas severe hypoglycemia results in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures, coma) which are unresponsive to diet modification. Severe PBH can be debilitating with a significant negative impact on quality of life. There is no approved pharmacologic therapy.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is identified, and for which an effective therapy is urgently needed. For more information, please visit the Company's website at www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a, lonafarnib, ubenimex or exendin 9-39, including SC formulation, may be further developed and approved, whether Phase 1 and Phase 2 studies of exendin 9-39 will show safety and activity consistent with early clinical results, including the interim results of the MAD study, or that the new liquid formulation will be consistent with results seen with IV and SC formulations of exendin 9-39, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and our periodic reports filed with the Securities and Exchange Commission. Eiger assumes no obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD email: ichoong@eigerbio.com Phone: 1-650-619-6115
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-industry-veteran-lisa-porter-md-to-lead-development-of-exendin-9-39-for-the-treatment-of-post-bariatric-hypoglycemia-300440724.html
SOURCE Eiger BioPharmaceuticals, Inc.
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EIGR
Ok. I haven't been tracking his trades lately. I took a starter today and given that data is this week, I'll hold through it. Even if positive data, this might be more like a slower multi day grinder even though float size suggests otherwise. Who knows if it gets big volume it may go parabolic on positive news imo
$heff did but he indicated so long after the fact so don't know when he sold. Presumably Dan Ward is still in according to Tweets.
I'm in. Been a real bust, but hopefully the abstracts aren't as bad as the market indicated. The analysts were supportive after they were released.
You holding till data presentation?
EIGR
He probably left long time back?
In EIGR @ $11.10 today. This is a $heff play (also Dan Ward):
Sheff? @SheffStation 21h21 hours ago
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$EIGR..$11.70 is going to move higher in April. One of my fav plays. Jefferies has a $28 PT & Oppenheimer a $34 PT. Many catalysts in Q2. pic.twitter.com/H9tKpLlCGw
Chart looks good, especially the MACD cross-over today and the SAR flip:
Low Float: Shs Float 8.02M
EIGR
Congrats to you and best of luck.
I would've have just about broke even if I held shares after R/S,so I didn't miss anything.
I wish you the best and hope it takes off and you make a boatload of cash.
Added 500 more shares today between $15.11-$15.64. Dirt cheap with what Eiger has in the pipeline. Will continue to add as I can if the price drifts lower......no material explanation for it.
EIGR
HPT
MMs shaking the tree hard for shares today.
EIGR
HPT
Understood. I will have an even 1000 after the R/S. Bought between .90-1.08 pre split. After R/S CLDN should trade higher than the $15 it will start at, so I should be right side up.
Usually don't like a R/S, but I think it will help CLDN/EIGR. Nice pipeline of orphan drugs and $59M cash to get them trialed and to market helps.
CLDN
HPT
I only had 10,000 shares so I bailed.I Would have only had 667 after split and would need a nice bump in PPS just to break even.
I'll revisit after the RS and see how it goes .I will monitor the trading to see if it's worth entering again.
Thanks for the heads up,appreciate it.
CLDN merger now complete. Will be a 1-15 R/S, new name on Weds, 7.3M O/S after all is said and done and $59M in cash. Look for a nice rise from $15
CLDN
HPT
Thanks for the update .
Meeting of Stockholders on March 21, 2016 at 12255 El Camino Real, Suite 300, San Diego, California 92130.
Yep,that's what I'm thinking.
It's messed up that us shareholders get screwed and Eiger makes out like a bandit. We been here propping up CLDN and they turn around and shaft us.
Yes,after mergers a short squeeze occurs,but I don't think 750,000 short shares will do much. Plus I never did trust these numbers.
http://www.nasdaq.com/symbol/cldn/short-interest
You will have 666 shares and .66 paid in cash. I am guessing that the share price should be around $19
I hear ya. I might sell after the short squeeze or at HOD, R/S day.
You don't lose money until the sell off after R/S
I know ,but I don't think my 10,000 shares will sway it one way or another.
10,000 that will soon be almost nothing .
Think I'll sell and get out.
That's what us common shareholders get for sticking around and supporting this company..NOTHING BUT A KICK YOU KNOW WHERE !
It still needs a vote
Yes I'm aware of this and thought you meant something else.
Eiger 78% of Celladon and the Celladon stockholders are expected to own 22% of Celladon.
That doesn't mean crap as Eiger is getting the better end of this deal.
They never mentioned the 1/15 in their first release..now they amended it .
Value of the combined companies
22% of what ..I'm confused ?
Read it again. We get a 1/15 RS and 22%
CLDN...They said our shares will not change. So the latest (s-4/a)has amended it ?
Our shares are Common. What ticker symbol did you buy?
But it won't affect my shares . I thought Our shares woould not change..correct ?
It's for CLDN common
OK thanks .
Hi RainerRocks,
I received your pm but am not currently a CLDN shareholder and haven't kept up with the company.
Marilyn
Wait..I thought the reverse stock split was for the Eiger shares and not not the Celladon common stock.
Ratio of 1-for-15
Anyone ?
Lower lows. Will it turn?
Lower highs and no news you might be right.
The double bottom is falling apart, a lot like the Panthers will in the second half of the Bronco's 3rd Super Bowl victory.
GLTU :)
Irresistible price right now. It's going to be a long weekend. Buying after the Panthers win.
Double bottom forming on the one month chart
Looking good for today.....from latest 8K
Looking good today.
CLDN
HPT
Looks like clearing or cover trades as the price only went up a few cents.
CLDN
SS
Two huge blocks after hour! More than 500.000 shares bought in few minutes!
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About the Proposed Merger
Existing Eiger stockholders as well as investors in the contemporaneous financing will receive newly issued shares of Celladon common stock in connection with the proposed merger. Celladon is expected to issue approximately 85.0 million new shares of its common stock to Eiger stockholders and participants in the financing. On a pro forma basis for the combined company, current Celladon shareholders are expected to own approximately 22%, current Eiger shareholders approximately 45% and the new Eiger investor syndicate approximately 33%, each on a fully-diluted basis.
The transaction has been unanimously approved by the boards of directors of both companies, and a majority of Eiger stockholders have agreed to vote in favor of the transaction. The proposed merger is expected to close in the first half of 2016, subject to the approval of the stockholders of each company as well as regulatory approval and other customary conditions. The merger agreement contains further details with respect to the proposed merger.
Celladon’s exclusive financial advisor in the transaction is Wedbush PacGrow Healthcare. Jefferies LLC is acting as lead financial advisor to Eiger and Piper Jaffray is acting as financial advisor. Pillsbury Winthrop Shaw Pittman LLP served as legal counsel to Celladon and Cooley LLP served as legal counsel to Eiger.
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