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Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017
http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-data-presentations-111100737.html
ENTA presenting at Wainwright NASH conference 4/3/17, 4pm ET:
http://finance.yahoo.com/news/enanta-pharmaceuticals-present-h-c-200100800.html
Bullish WSJ profile on ENTA: #msg-129765873.
ENTA's pro forma EV is only $284M: #msg-129620784.
G/P receives priority review in Japan:
#msg-129490648
G/P now has priority reviews in the US, EU, and Japan, and will likely be on the market in all three jurisdictions by the end of 2017.
CHMP approves 8-week duration of Viekirax/Exviera for treatment-naïve GT1b:
#msg-129037247
ENTA slides from RBC webcast—new slide re FXR agonists:
#msg-128915696
New ENTA slide set (from today’s Leerink webcast):
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyNDkxMjV8Q2hpbGRJRD02NjAyNTA=
ENTA cash at 12/31/16 was $244.4M—an increase of $2.0M since 9/30/16:
http://finance.yahoo.com/news/enanta-pharmaceuticals-reports-financial-results-210200919.html
See #msg-126723412 for related info.
CC at 4:30pm ET.
ENTA webcasts at Leerink and RBC:
http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2243372
FDA grants priority review for G/P regimen: #msg-128359345.
ABBV’s 2017 Viekira sales guidance is $1.0B, implying a further slowdown from the 4Q16 run rate. For ENTA investors, G/P can’t come soon enough.
4Q16 Viekira sales $311M, -18% QoQ: #msg-128193393.
FDA priority review is almost certain given that G/P has FDA BTD.
I'm surprised this didn't even give the stock a little boost. Hopefully it's followed by FDA priority review announcement.
EMA grants accelerated assessment for G/P HCV regimen: #msg-128090944.
FY1Q17 CC will be 2/8/17 at 4:30pm ET:
http://finance.yahoo.com/news/enanta-pharmaceuticals-host-conference-call-141700356.html
BlackRock upped its stake from 10.4% to 10.9% during Dec 2016: #msg-127821845.
ENTA’s JPM slides contain new info on non-HCV pipeline:
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyNDU0NjZ8Q2hpbGRJRD02NTY4MDM=
ENTA reports near-perfect G/P data in Japanese patients: #msg-127727429.
Musings on discontinuation of EDP-494: #msg-127673557.
Today's PR on 2017 news flow:
http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2234664
EDP-305 for NASH gets FDA Fast Track designation: #msg-127607645.
ENTA webcast at JPM: 1/11/17 at 12:00pm ET (9am PT) for the presentation and 12:30pm ET for the Q&A session.
(The company's recent PR gave the date but not the time of the webcasts. I confirmed with above with IR.)
Links and context wrt G/P NDA submission: #msg-127281791.
Enanta Pharmaceuticals Announces AbbVie’s Submission of NDA for Investigational, Pan-Genotypic HCV Regimen of Glecaprevir/P...
Alert
ENANTA PHARMACEUTICALS INC (NASDAQ:ENTA)
Intraday Stock Chart
Today : Monday 19 December 2016
If approved, G/P will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes
AbbVie’s investigational regimen was granted Breakthrough Therapy Designation by the FDA for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)
G/P includes Enanta’s second protease inhibitor, glecaprevir (ABT-493)
AbbVie is on track to submit Marketing Authorization Application for G/P in the European Union in early 2017
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that AbbVie has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, pan-genotypic, fixed-dose combination of glecaprevir (ABT-493) and pibrentasvir (ABT-530) (G/P), being evaluated for the treatment of chronic HCV. In Phase 3 clinical studies, eight weeks of therapy with G/P demonstrated high sustained virologic response (SVR) rates across all major genotypes (GT1-6) in patients without cirrhosis and who are new to treatment, which represent the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). In historically difficult to treat populations, including those not cured* by prior direct-acting antiviral (DAA) treatment regimens, high rates of SVR were achieved with durations as short as 12 weeks.
“We are pleased with the data that AbbVie has submitted with this NDA, and that once-daily G/P has the potential to bring an 8-week treatment option to treatment-naïve, non-cirrhotic HCV patients across all major genotypes,” stated Jay R. Luly, Ph.D.
The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations. Patient populations studied included all major genotypes, new and experienced to treatment, those with and without cirrhosis and patients with specific treatment challenges, including those with severe CKD, and those who have failed a DAA-containing regimen.
AbbVie previously announced registrational data that show with eight weeks of treatment, 97.5 percent (n=693/711) of chronic HCV patients across all major genotypes (GT1-6) without cirrhosis and new to treatment achieved SVR12. Additional data submitted show that with 12 weeks of treatment, 98 percent (n=102/104) of severe CKD patients achieved SVR12 in a primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis of severe CKD patients, 100 percent (n=102/102) of patients achieved SVR12. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. The most commonly reported adverse events (AEs) for severe CKD patients were pruritus, fatigue and nausea. The most commonly reported AEs for GT1-6 patients without cirrhosis and new to treatment were headache and fatigue. These data were presented at The American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016. Data for other registrational studies will be shared at future meetings.
On September 30, 2016, AbbVie announced that the FDA granted Breakthrough Therapy Designation (BTD) for G/P for the treatment of patients with HCV who failed previous therapy with DAAs in GT1, including therapy with an NS5A inhibitor and/or protease inhibitor. The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.1
AbbVie has announced it is on track to submit a marketing authorization application for G/P in the European Union in early 2017.
About AbbVie’s Clinical Development of G/P for HCV
G/P is an investigational, pan-genotypic regimen that is being evaluated by AbbVie as a potential cure* in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.
G/P is a once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.
Glecaprevir is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie and is one of the two new direct-acting antivirals in G/P.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of HCV.
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta’s research and development efforts are currently focused on four disease targets: Hepatitis C Virus (HCV), Non-alcoholic Steatohepatitis (NASH), Respiratory Syncytial Virus (RSV) and Hepatitis B Virus (HBV).
Enanta has discovered novel protease inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta’s collaboration with AbbVie, include paritaprevir, which is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir (ABT-493), Enanta’s second protease inhibitor product, which AbbVie has developed in Phase 3 studies as part of an investigational, pan-genotypic, once-daily, ribavirin-free, fixed-dose combination (G/P) with pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor. In addition to the recent NDA filing with the FDA, AbbVie has announced it is on track to submit a marketing authorization application for G/P in the European Union in early 2017.
Enanta has also discovered EDP-305, an FXR agonist product candidate for NASH, currently in Phase 1 clinical development, as well as a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is also in Phase 1 clinical development. In addition, Enanta has early lead candidates for HBV and RSV in preclinical development. Please visit www.enanta.com for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s investigational G/P treatment regimen for HCV. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the efforts of AbbVie (our collaborator developing glecaprevir) to obtain regulatory approvals of its glecaprevir/pibrentasvir(G/P) combination and commercialize it successfully; the regulatory and marketing efforts of others with respect to competitive treatment regimens for HCV; regulatory and reimbursement actions affecting G/P, any competitive regimen, or both; the need to obtain and maintain patent protection for glecaprevir and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for the fiscal year ended September 30, 2016 and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
________________________________
1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed November 23, 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161219005598/en/
Investor Contact
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
The FY2016 10-K has been filed:
https://www.sec.gov/Archives/edgar/data/1177648/000119312516789660/d245582d10k.htm
BlackRock upped its stake to 10.4% on 11/30/16 from 8.9% on 12/31/15—an increase of ~300K shares:
#msg-127137556
GILD submits NDA for SOF/VEL/VOX HCV regimen: #msg-127098862.
Enanta in HCV. Here are the 3 main players and recent AASLD studies
http://www.natap.org/2016/AASLD/AASLD_64.htm
Model assumptions: 30% G/P market share; pricing similar to Harvoni and Viekira (net of discounts and rebates).
Note that ENTA gets a 67% higher royalty per dollar of G/P sales than they do per dollar of Viekira sales.
What pricing and market share assumptions did you use on G/P ?
ENTA appoints former TEVA executive to BoD: #msg-126730864.
ENTA could earn $9.50/sh in 2020: #msg-126723412.
ENTA's enterprise value is cheap: #msg-126720919.
FY4Q16 financial results/cash balance: #msg-126720369.
I just saw on twitter that ENTA has a patent on a hep B compound.
It's at the top of the pile now;
https://twitter.com/search?q=%24ENTA&src=ctag
tweeted by this fellow; "Dr. Zoidberg"
https://twitter.com/psuvafan007
Late breaker presentation 2nd gen G/P
8 weeks treatment Genotype 2, 4, 5, or 6
http://www.natap.org/2016/AASLD/AASLD_40.htm
SURVEYOR-II, Part 4: Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients With HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis Following an 8-Week Treatment Duration
Hep B has proven to be a tough nut to crack.
I don't think this will be a drug that will be used on HBV.
I've seen a few investigations that were HCV related, and I think one HBV related; I didn't think that a cyclophilin inhibitor use could be so broad.....but I saw someone was attempting it.
At one of the stock pitches someone asked Jay Luly about it; He seemed almost unaware of a different cyclophilin drug in development, very non committal about it's use for HBV, but I got the impression that it wasn't in the cards for this specific compound.
I hope that Luly will take about the compound at the ENTA earnings meeting later this month.
I will remember to keep my eye out and let you know if I see something interesting/promising.
Hey this stuff also works on HepB right ? All the HepB drugs in trials that I follow have gone down in smoke. So I am kinda sad. I sure hope a HepB cure will come along soon (5-10 yrs) although there is nothing that would come to my mind right now.
I remember reading somewhere that CI and something that works against cccDna together may do the trick in HepB.
I posted the EXPEDITION-4 results in #msg-126567102 (same PR).
Enanta Pharmaceuticals Announces AbbVie’s Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease
http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2222520
98 percent of patients across all major HCV genotypes (GT1-6) with severe chronic kidney disease (CKD), including patients on dialysis, achieved SVR12 with 12 weeks of G/P in the primary intent-to-treat analysis, regardless of previous treatment status or presence of compensated cirrhosis
100 percent of patients achieved SVR12 in a modified intent-to-treat analysis
G/P is an investigational, pan-genotypic, once-daily, ribavirin-free, fixed-dose combination for the treatment of chronic HCV
G/P includes Enanta’s second protease inhibitor glecaprevir (ABT-493)
More G-3 data from AASLD
(note this contains verification that dosing was be 3 pills (3- 100mg/40/mg pills)
SURVEYOR-II, PART 3: EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR (ABT-493/ABT-530) IN PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 3 INFECTION WITH PRIOR TREATMENT EXPERIENCE AND/OR CIRRHOSIS
http://www.natap.org/2016/AASLD/AASLD_20.htm
compare to Gilead's G-3 Epclusa data
High Efficacy of Sofosbuvir/Velpatasvir In HCV Genotypes 1-6 Infected Patients With Cirrhosis: Pooled Data From the ASTRAL 1, 2 and 3 Trials
http://natap.org/2015/hepDART/hepDART_09.htm
It is a little complicated (or daring leap) since I don't know how each defined treatment experience and what percentage was interferon based versus DAA experienced and differing types of exposures and resultant RAVs
Per this link you can see about past mid point is the table
"SVR by Treatment History in Patients with Cirrhosis"
which shows that Sof/Vel in G-3 resulted in cure rates of;
93% in treatment naive patients w/ cirrhosis (40/43)
89% in treatment experienced patients w/ cirrhosis (33/37)
==================
Compare to Abbvies G/P 2nd gen from above link;
http://www.natap.org/2016/AASLD/AASLD_20.htm
Phase 2 data ("Background and objectives table")
100% SVR in TX naive patients w/ cirrhosis. 12 wk (24/24)
92% SVR in TX experienced patients w/ cirrhosis 12 wk (22/24)
Surveyor part 3
98% SVR in 12 wk tx naive patients w/ cirrhosis (39/40)
91% SVR in 12 wk treatment naive patients w/ cirrhosis (20/22)
96% 16 week treatment experienced w/o cirrhosis (21/22)
96% 16 week treatment experienced with cirrhosis (45/47)
For me Abbvie data looks very competitive..... superior in G-3 to Gilead's
Adding 4 more to treat the hardest to treat group doesn't seem to be excessive for a 16 week total.
I still admit it would be good to see definitions and percentages of treatment experienced since it will make a great difference to results. This seems to be what I could find, however.
This kind of comparison is important since these are the two front line programs Gilead's Epclusa vrs Abbvies G/P 2nd gen.
In the United states this is where the majority of business should be; in G1 primarily, but also in G-3 since it is a previously harder to treat genotype and prior to Epclusa very very expensive, and with some warehousing of patients. (in USA and world wide)
EDP 494 Enta's cyclophilin inhibitor
http://www.aasld.org/sites/default/files/2016-AbstractSupplement-TheLiverMeeting.pdf
1453
Safety, Tolerability, Pharmacokinetics (PK) and Antiviral
Activity of EDP-494 a Potent Pan-Genotypic Cyclophilin (Cyp) Inhibitor for Chronic Hepatitis C Infection (CHC), in Healthy Subjects (HS) and in CHC Genotype 1 and 3
Patients: Preliminary Result
Background:
Current HCV Direct Acting Antiviral therapies
(DAAs) are not pangenotypic and can select for resistant
variants, thereby limiting retreatment options. Host Targeting Agents (HTA), like EDP-494, an oral Cyp inhibitor are being developed in response to this unmet medical need
The key objectives of this randomized, double-blind, placebo (P)-controlled single ascending dose (SAD) and food effect (FE) in HS and multiple ascending doses (MAD) in HS and in patients with CHC (POC) were to identify a safe and pharmacodynamically-active dose to be used in subsequent clinical studies.
[NCT0265237]
Methods:
Healthy and CHC men and women
(non-childbearing potential) aged 18-55/70 years were ran-
domized to receive a single (SAD) or multiple (MAD, POC) oral doses of EDP-494 or P.
In the SAD, 6 cohorts were evaluated, each containing 8 subjects (6 EDP-494, 2 P), starting with 50 mg followed by 100, 200 (fasted & fed), 400, 800 and 1200 mg.
In the ongoing MAD, 3 cohorts (200, 400 and
800 mg QD) of 8 subjects each have completed 14 days of
dosing and 1 week of follow-up. Safety assessments included
adverse events (AEs), vital signs, ECG and clinical laboratory
parameters. Serial blood samples were drawn for PK evalua-
tion.
Final SAD/ FE, and preliminary MAD results are reported
here; final MAD and preliminary POC results will be available at the time of presentation
.
Results:
All enrolled subjects but 2 who withdrew consent (72/74) completed the study (all males; mean age 28 years).
28/60 (47% SAD subjects) and 13/24 (54% MAD subjects) reported at least 1 AE. All AEs but one were mild and the most frequent were GI symptoms, headache and venipuncture bruises. There were no Grade 3 or 4 AEs, SAEs, discontinuations due to AEs, or dose-limiting toxicities.
Maximum tolerated dose was not reached in
the SAD and dose escalation continues in the MAD.
In SAD cohorts, exposure to single doses of EDP-494 increased in a dose-proportional manner (mean plasma Cmax, AUC0-24hr and AUC0-168hr).
Absorption was rapid with a median Tmax of 3-5 h.
As expected, higher concentrations of EDP-494 in blood compared to plasma were observed
.
Conclusions:
EDP-494 had a favorable safety profile and was well tolerated in
healthy subjects based on final and preliminary analysis of
subjects receiving a single dose up to 1200 mg or multiple QD
doses up to 800 mg for 14 days
.
EDP-494 also demonstrated a desirable PK profile, with rapid absorption, low PK variability, long half-life and dose-proportional exposure .
Preliminary viral kinetic data in the POC patients will be presented
Phase II studies are planned to explore combinations of this new HTA with DAAs in different patient populations.
===========================
(not much to comment on); it appears to be safe.
I haven't heard about the viral kinetics.
Since it is host based and not subject (or less so) resistance it had a longer monotherapy period. In this I would/could expect a large viral decline. Luly barely spoke about it as the last stock pitch.... I'm very interested in seeing how it did; heard nothing on twitter.
Most of the ENTA AASLD talk on twitter was NASH
http://www.aasld.org/sites/default/files/2016-AbstractSupplement-TheLiverMeeting.pdf
(page 420)
849
Analysis of HCV Variants in the MAGELLAN-1 Part 1
Study: ABT-493 and ABT-530 Combination Therapy
of Genotype 1-Infected Patients Who Had Failed Prior
Direct Acting Antiviral-Containing Regimens
North Chicago, IL
Background: ABT-493 (NS3/4A protease inhibitor [PI] iden-
tified by AbbVie and Enanta) and ABT-530 (NS5A inhibitor) are next generation HCV direct-acting antiviral agents (DAAs).
Co-administration of ABT-493 + ABT-530 achieved a high
sustained virologic response 12 (SVR12) rate in DAA-naïve
patients with HCV genotype (GT) 1-6 infection, as well as GT1-infected patients who had previously failed a DAA-containing regimen.
.
In this report we present the characterization
of variants detected in samples from subjects enrolled in Part 1
of the MAGELLAN-1 study: treatment with ABT-493 + ABT-530
± RBV for 12 weeks in non-cirrhotic GT1-infected patients who
had previously failed regimens containing a PI and/or NS5A
inhibitor, ± an NS5B polymerase inhibitor.
Methods: Next generation sequencing (NGS) was performed on HCV NS3/4A and NS5A genes from all baseline samples and the first available sample after virologic failure with HCV RNA ≥
1000 IU/mL.
Sequencing results at 1% and 15% detection cutoffs were
examined for the presence of resistance-associated variants (RAVs) in the NS3 and NS5A genes.
Results: NGS (with 1% cutoff) of baseline samples from all patients (n=50) identified RAVs in 41 (82%) patients:
15 (30%) in NS3 only,
10 (20%) in NS5A only, and
16 (32%) in both targets
.
In 90% (37/41) of these samples, the RAVs were also present using an NGS detection cutoff of 15%. These DAA-experienced patient cohorts had broad representation of baseline variants at key resistance-associated positions, including those at NS3 V36, Q80, R155, and D168, as well as NS5A M28, Q30, L31, and Y93
.
All patients with baseline variants at position Y93 in
NS5A that confer high level of resistance to currently approved
NS5A inhibitors achieved SVR12 (n=10)
.
Of the 2 out of 50
(4%) patients who experienced virologic failure, 1 patient had
baseline NS3 (Y56H and D168A/T) and NS5A (M28V and
Q30L/R) RAVs, and the other patient had baseline RAVs in NS5A (L31M and H58D) only.
Conclusions: The combination of ABT-493 and ABT-530 demonstrated potent antiviral activity
and a high barrier to resistance in non-cirrhotic HCV GT1-in-
fected patients who had previously failed a DAA-containing regimen, regardless of the diverse profile and high prevalence of baseline NS3 and/or NS5A RAVs among these patients. These promising results support the study of this combination regimen in a larger cohort of DAA-experienced patients.
The renal impairment trial results- late breaker
http://www.aasld.org/sites/default/files/LBA%20Full%20Abstracts%20Final%20%28Trimmed%29_1.pdf
(page 8)
HEPATOLOGY, VOLUME 64, NUMBER 6 (SUPPL)
AASLD ABSTRACTS
1125A
LB-11
EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults
with renal impairment and Chronic Hepatitis C Virus
Genotype 1 – 6 Infection
" Here we report on the safety and
efficacy of GLE/PIB administered for 12 weeks in GT1-GT6
HCV-infected patients with severe renal impairment (GLE was
identified by AbbVie and Enanta).
"RESULTS:
A total of 104 partici-
pants (76% male and 62% white) were enrolled in this study,
of whom 42% were TE and 19% had compensated cirrho-
sis. Patients had either GT1 (52%), GT2 (16%), GT3 (11%),
GT4 (19%), GT5 (1%) or GT6 (1%) chronic HCV infection and
had either CKD stage 4 (13%) or stage 5 (87%); 82% were
on dialysis. SVR4 was achieved by 103/104 (99%) patients.
The patient not achieving SVR4 prematurely discontinued treat-
ment. Most treatment emergent adverse events (AEs) were mild
or moderate in severity. Of the 24% of patients who experi-
enced serious AEs, none were related to study-drug. Four AEs
(4%) led to study-drug discontinuation and one patient died
after achieving SVR4 due to a serious AE not-related to study
drug (intracerebral hemorrhage).
CONCLUSIONS
The fixed
dose combination of GLE/PIB administered once daily for 12
weeks was well tolerated in patients with severe renal impair-
ment with 99% of patients achieving SVR4. Serious AEs were
considered unrelated to study drugs and associated with the
patients’ underlying comorbidities. T"
Comparing Abbvie's 2nd gen(G/P) to Gilead's triple.
http://www.aasld.org/sites/default/files/LBA%20Full%20Abstracts%20Final%20%28Trimmed%29_1.pdf
1126A
AASLD ABSTRACTS
HEPATOLOGY, December, 2016
LB-12
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/
Voxilaprevir for 8 Weeks Compared to Sofosbuvir/
Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6
HCV-Infected Patients: The POLARIS-2 Study
=======================
(I have cut out some parts-view page to see full details~W)
This Phase 3 study (NCT02607800)
compared treatment with SOF/VEL/VOX fixed dose combi-
nation (FDC) for 8 weeks to SOF/VEL FDC for 12 weeks in
patients with genotype 1-6 HCV infection with and without
compensated cirrhosis who have not previously received treat-
ment with an HCV direct-acting antiviral agent (DAA).
Now compare to the Abbvie 8 week results;
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126481635
What appears to be a comparable test group
Genotype 1... ABBV G/P 8 wk 99% (348/351)
.......................GILD S/V/V 8 wk 96% (482/501)
Genotype 3...
...........ABBV G/P 8 wk 95% tx naivenon & noncirrhotic
...........GILD S/V/V 8 wk 100% (92/92) w/ % cirr
Genotype 2, 4, 5, & 6.. ABBV G/P 8 wk 97% (196/203)
........GILD S/V/V 8 wk G-2 97 (61/63)
.............................G-4 94 (59/63
.............................G-5 94 (17/18)
.............................G-6 100 (30/30)
GILD group G-2, 4, 5 & 6 is 174 patients compared to ABBV 203
The data shows very comparable 8 week results.
There is one difference however;
per the gilead late breaker
the group was DAA naive
On the other hand it appears that some exposure to sovaldi was allowed into Abbvie trials.
(from the endurance trial; HCV treatment-naïve or treatment experienced (IFN or pegIFN with or without RBV; SOF plus RBV with or without pegIFN).")
So there were some % of cirrhotics in Gilead trials; non in the abbvie
Obviously, not a 100% apples to apples comparison
Even so..... we will be able to detect some of the weaknesses when we compare therapies in shorter threshold treatment durations.
Both therapies look quite strong at 8 weeks and both will look very good at 12 weeks
This indicates to me that the Abbvie program looks very good compared even to Gileads triple; the top gun reserved for salvage.
I know it isn't a perfect comparison, but it is possible to look at comparable groups in 8 weeks. Thoughts? Any mistakes?
I'm busy and haven't looked at all the other trials or compared, but this looked noteworthy.
Worth mention.... some of the presentations at AASLD will provide final SVR data, so until that is known that final comparison isn't possible
~W
MRK’s 3-DAA HCV regimen fails to impress: #msg-126517784.
ENTA presents preclinical data for NASH compound, EDP-305 at AASLD:
#msg-126481843
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03/20/13
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Moderators DewDiligence |
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