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I think shorts are screwed
$HEPA: NEWS out...... Ambition Trial going well
Additional Data from Hepion Pharmaceuticals’ Phase 2a ‘AMBITION’ Trial Further Strengthens CRV431 Clinical Profile and Paves Way for Initiation of Phase 2b ‘ASCEND-NASH’ Clinical Program
September 13, 2021 08:00 ET | Source: Hepion Pharmaceuticals, Inc.
...
Pro-C3 and ALT reductions point to anti-inflammatory and antifibrotic effects of CRV431
PK-PD models successfully predict early reductions in Pro-C3 and ALT
Hepion’s proprietary AI-POWR™ and machine learning accurately predict CRV431 responders
Anti-fibrotic gene expression signature revealed in bioinformatic analyses
Phase 2b activities initiated
EDISON, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced additional efficacy data from its Phase 2a AMBITION clinical trial.
AMBITION, a multicenter, randomized, placebo controlled, single-blind Phase 2a trial, enrolled 43 NASH patients. The trial was designed to investigate once daily oral administration of CRV431 at doses of 75 mg (n=12) and 225 mg (n=17) administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.
As previously reported, all primary endpoints of the AMBITION NASH trial (safety, tolerability and pharmacokinetics) were met.
Today, Hepion reports additional data on biomarkers, alanine aminotransferase (“ALT”) and N-terminal type III collagen pro-peptide (“Pro-C3”), as well as advanced pharmacologic and bioinformatic analyses that indicate CRV431 efficacy in treating NASH patients.
Once-daily 225 mg dosing of CRV431 decreased mean Pro-C3 levels by 7.9% (-2.1 ng/ml) and 22.4% (-11.6 ng/ml) at days 28 and 42, respectively, in subjects stratified for baseline Pro-C3 levels greater than 17.5 ng/mL (n=7). Pro-C3 levels greater than 15-20 ng/ml are generally accepted to represent active NASH disease activity and the primary patient population for treatment by many NASH drug candidates. In contrast to the 225 mg CRV431 cohort, placebo treatment similarly stratified by baseline Pro-C3 greater than 17.5 ng/mL (n=9) resulted in a mean increase of 3.5% (0.7 ng/ml) and a mean decrease of 4.7% (-1.6 ng/ml) at days 28 and 42, respectively. The same Pro-C3 baseline stratification for the 75 mg CRV431 dose (n=11) resulted in a mean decrease in Pro-C3 of 9.1% by Day 42, indicating a dose-dependent effect. When stratified for baseline Pro-C3 levels greater than 15.0 ng/mL, 225 mg once daily CRV431 (n=9) reduced mean levels by 4.1% and 14.3% at days 14 and 28 days, respectively, compared to a mean increase of 1.5% and a decrease of 8.8% in the placebo group (n=9) at days 28 and 42, respectively. The reductions in Pro-C3 produced by CRV431 treatment mirror the previously reported dose-dependent declines in ALT.
Importantly, more detailed analyses of the AMBITION trial data using Hepion’s proprietary AI-POWR™ platform provided further evidence of CRV431 efficacy in the treatment of NASH. First, pharmacokinetic-pharmacodynamic (“PK-PD”) analyses were able to generate robust models that could predict whether individual patients would show reductions in ALT and Pro-C3 based on CRV431 exposure, baseline ALT, Pro-C3, and other demographic and clinical measurements. Second, analysis of full-genome, ribonucleic acid (RNA) sequencing data (“transcriptomics”) from the patients revealed that CRV431 treatment produced changes in gene expression that were consistent with anti-fibrotic effects. Labelled as a collagen-related gene regulatory network, the CRV431-induced changes in gene expression included six key collagen isoforms, and many other structural and enzymatic constituents of the fibrotic matrix. In similarity to the PK-PD models for ALT and Pro-C3, supervised machine learning analyses were able to categorize patients as responders or non-responders based on their transcriptome responses to CRV431 treatment.
“The decline in Pro-C3 that was observed in the AMBITION trial puts us well within the range of NASH data published by other companies with later-stage NASH drug candidates,” said Hepion’s Chief Medical Officer, Todd Hobbs MD. “But notably, these declines in Pro-C3 with CRV431 occurred in only 4 weeks, compared to declines with other agents, where the changes occurred over several months.”
“These biomarker findings offer us two important insights. First, CRV431 has sustained effects, as evidenced by the Pro-C3 changes at day 42. The long terminal half-life of CRV431 can explain these findings and, in fact, circulating blood concentrations of CRV431 are present at day 42, even though drug administration stopped on day 28,” said Hepion’s Senior VP, Clinical Pharmacology & Analytics, Patrick Mayo, PhD.
“Second, the most recent data generated from our AMBITION trial has allowed us to put our machine learning and proprietary AI-POWR™ to work,” continued Dr. Mayo. “We have been able to construct models that may predict a priori who will respond to CRV431. In this context, we believe that we can predict how much of a reduction in ALT and Pro-C3 may be expected in any given subject, even as early as the first administered dose of CRV431. Indeed, we demonstrated that this works very elegantly in predicting ALT and Pro-C3 responses of subjects in the AMBITION trial with a high degree of accuracy. The PK-PD modeling also demonstrated great accuracy in predicting clinical response, as indicated by modeling diagnostics including predicted versus observed plots. Moreover, we have used our transcriptomics to investigate and construct a network of genes that gave us a very consistent picture of antifibrotic effects when CRV431 was tested in the latest clinical program. Interestingly, we also looked at these same genes in our preclinical animal models, our cellular assays, and our studies of human liver slices, and we observed the same findings with the collagen-related gene network.”
“These powerful tools allow us to investigate CRV431 in silico which should allow us to simulate future trials before conducting them in the clinic. The more data we feed into our AI, the more the AI will learn. This, in turn, should enable us to be very precise in this very heterogenous NASH disease. Our AI, therefore, is a very powerful and important tool. The Phase 2a study provided a treasure-trove of information that has allowed us to fine-tune our AI and adjust the design of our planned Phase 2b study,” concluded Dr. Mayo.
Robert Foster, PharmD, PhD, Hepion’s CEO, commented, “Dr. Mayo and his team are conducting truly ground-breaking work. Many of us at Hepion have been working on cyclophilin inhibitor drug development for the better part of three decades. But, any kind of drug development is inherently risky, especially when relying solely on traditional tools. We believe we may now be able to mitigate a great deal of development risk with the AI and machine learning tools developed and utilized by our clinical pharmacology group. The fact that our team has been able to identify early changes in important biomarkers and in collagen genes, while developing predictive responder analyses, should help propel us in the NASH drug development space. Ultimately, our goal is to employ our models to optimize trial design, efficiency, cost, and outcomes, while mitigating development risk. In many ways, we believe that what we are doing is unprecedented in NASH drug development. We are confident that the AMBITION trial and our detailed analyses set the stage for success in the upcoming and larger Phase 2b program called, ASCEND-NASH.”
The full AMBITION analysis will be presented by Stephen Harrison, MD, at the upcoming AASLD “The Liver Meeting,” in early November 2021.
Conference Call & Webcast Details
Hepion is pleased to invite all interested parties to participate in a conference call today at 8:30 a.m. ET, during which both the Phase 2a AMBITION trial data and the design of the planned Phase 2b ASCEND-NASH trial will be discussed. To participate telephonically, please dial (855) 493-3481 (U.S.) or (929) 517-0949 (international), conference ID 3568976, approximately 10 minutes prior to the start time. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the “Events” page of the “Investors” section at www.hepionpharma.com. An archive of the webcast will be available for approximately 90 days following the conclusion of the conference call.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
We all know companies will do it at ANY price ;)
Either way, we'll know soon enough.
listen to the event here: https://edge.media-server.com/mmc/p/cxdssmij
$HEPA
Conference call before open, and I'm thinking offering after close. Wouldn't surprise me if we see one soon.
Hepion Pharmaceuticals Inc (NASDAQ:HEPA) stock is moving higher during premarket ahead of additional data from its non-alcoholic steatohepatitis (NASH) trial.
Today, Hepion will share additional data from the Phase 2a AMBITION trial, evaluating CRV431, a potent inhibitor of cyclophilins involved in many disease processes.
As previously disclosed, the trial achieved all primary endpoints.
Related Content:Hepion Pharma's NASH Candidate Aces Mid-Stage Study.
Price Action: HEPA shares are up 16.9% at $1.94 during the premarket session on the last check Monday.
Already at 1.93 it's past the 200dma I'm looking at 2.30 but if the call gives some very positive data it may open that high
Hey Bert! Tomorrow's CC should help HEPA run $2.00+
HEPA $1.93 mm’ will be up very early for tomorrow
If it does you certainly want to be holding some warrants, I hold both.
Fress Check this...
Travis Fisher and Kevine Donahoe both "liked" Hobbs linkdin post about the conference call....both dudes are top execs at Novo..hmmmmm. BOOM!
$HEPA
Every study I’ve read containing CRV431 has been overwhelmingly positive! Something big is coming….
go $HEPA
$HEPA Long and strong diamond hands. Monday's price action should be interesting.
$HEPA "it would not be strange to see Hepion's Market Cap surpass $1 billion." That's $13+ per share target folks!
$HEPA
This is the guy with $13 outlook. Wonderful ranking on seekingalpha
https://twitter.com/Ultra_Calls/status/1435659979495813124
$HEPA Global Nonalcoholic Steatohepatitis Market $20 Billion by 2027
https://www.ihealthcareanalyst.com/global-nonalcoholic-steatohepatitis-treatment-market/
$HEPA
expects to release additional data from its Phase 2a ‘AMBITION’ NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial. #NASH
$HEPA
#NASH Holy grail, Market in billions. @25 it will be 2 billion in market cap.
Dr. Hobbs will help lead Hepion's engagement with the U.S. Food and Drug Administration ("FDA"), global and national thought leaders, key policymakers, and professional associations.
$HEPA up after hours $1.91
It's been a long time my friend. That's good stuff. And i particularly love how they have trapped the shorts with the late P/R
idk what the short interest is here but lets hope its going to be very high
Good to see you here crude
Opening bell upside gapper > Monday
Looking good… go $HEPA
Hepion Pharmaceuticals Schedules Conference Call To Review Data From Phase 2a 'AMBITION' Clinical Trial Of CRV431 in NASH
4:05 pm ET September 10, 2021 (Benzinga) Print
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced that it expects to release additional data from its Phase 2a ‘AMBITION' NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial.
Hepion is pleased to invite all interested parties to participate in a conference call and webcast at 8:30 a.m. ET on September 13, during which the previously disclosed AMBITION topline results, as well as the additional new data, will be discussed.
To participate telephonically, please dial (855) 493-3481 (U.S.) or (929) 517-0949 (international), conference ID 3568976, approximately 10 minutes prior to the start time. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the "Events" page of the "Investors" section at www.hepionpharma.com. An archive of the webcast will be available for approximately 90 days following the conclusion of the conference call.
YES
$HEPA buyers are back in afterhours..... crazy volume today.... $2.2 next pivot
— Antonio Costa (@ACInvestorBlog) September 8, 2021
$HEPA: This is by far the Hottest Play in the NASH space
Don't listen to what anyone else says.
Take what I say........ and RUN with it
GO $HEPA
Hepion Pharmaceuticals: A Promising Early-Stage Biopharma In The NASH Race
https://seekingalpha.com/article/4454057-hepion-pharmaceuticals-a-promising-early-stage-biopharma-in-the-nash-race
Aren’t earning coming out AH today? Not that is would really mean much other than giving us a few details.
$HEPA There are 76 million HEPA shares outstanding. >95% institutional ownership.
No filings were submitted for ~70% of the 64 million shares bought at the November and February offerings, meaning the vast majority was concealed. Before institutions bought 64 million shares at those offerings, there were 12 million shares out, with 3 million in the public float.
So, direct holders had ~9 million shares of that, and tutes got 64 million shares at the offerings, which possibly left ~3 million shares for retail then.
Also the chart just reversed.
Company has 120 million in the bank burning under 5 million a quarter!
$HEPA ready to bounce from the bottom $2 breakout this week IMO
$HEPA: $2.30 next stop................
Gotta love this green vol bar on the chart today.
Resistance level could come up before this week is thru.
Now at 1.83
GO $HEPA
If it does you want some CTRVW
$HEPA: Lets see HEPA fire off like $EFTR
right now.
It can happen.
Letssssssssssss goooooooooooooooooooo
GO $HEPA
I believe there was another filed on Sept 2 that was for treating cancer. This company is a great mystery. Gltu
U.S. patent application number 17/179406 was filed with the patent office on 2021-08-26 for use of cyclosporine analogues for treating fibrosis. The applicant listed for this patent is Hepion Pharmaceuticals, Inc.. Invention is credited to Robert T. Foster, Patrick R. Mayo, Daniel J. Trepanier, Daren R. Ure.
https://uspto.report/patent/app/20210260153
i feel like a lot of ppl will want to start jumping ship at that point. i'm going to stick it out and see what happens
Enough already, back to $2, lol
This is great news … spread the word!!!
https://uspto.report/patent/app/20210260153
i avg. down once on this. just a small position and i have no problem w/holding. Still heavy in PDS. Thats my winner
i think they outed a few bad eggs
Any thoughts on new shareholder meeting and lowering of quorum to 33%?
I think some have sold for a loss, but I will wait. I like their data from CRV431 and we should hear more soon...
Looks like we all have no choice but to wait. And that’s what we do. So strange of the utter silence around here.
$HEPA ...
I´m holding strong with $2.08 avg. not going to sell before multi dollars.
Strong hands LT play here..
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Hepion Pharmaceuticals (Nasdaq: $HEPA) is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV).
Hepion announced top line data from the low dose cohort in the Company's Phase 2a ‘AMBITION' clinical trial of CRV431, an oral, once daily novel cyclophilin inhibitor. This Phase 2a study is continuing with the higher dose of 225 mg CRV431, with NASH patient dosing expected to be completed in Q1-2021.In 2021, of the more than 300 million people living with HBV infection, 10.5% (27 million) were aware of their infection. Non-alcoholic Fatty Liver Disease (NAFLD) affects up to 25% of people in the United States. There are currently no medicines that can cure non-alcoholic Fatty Liver Disease effectively. The same can be said with HBV. With the momentum growing around hepatitis B drug discovery research, we are closer than ever to a cure.
Fact: The inflows have been massive the last 2 weeks. Reason why In just 28 days at the low dose, HEPA CRV431 results were as good as what Madrigal's P3 lead NASH drug took 12 weeks to accomplish.
Bottom line The FDA looks for safety first we have the safest NASH drug our efficacy data is better than MDGL & AKRO. there market caps our almost 10x HEPA. Smart savvy biotech investors with deep pockets know this and are accumulating all they can of HEPA at these levels.
One morning we can wake up and see the price has tripled from its 160 market cap. Also they have 120 million in cash burning under 5 million a quarter. Lots of moving parts here. Gilead & Novo in the mix we will see? A new molecule being added to the pipeline. This management team is experienced 100 years total and world renown experts on cyclophilin inhibitors. They brought a FDA approved blockbuster drug to market already.
June 2021 Hepa Biz Presentation
https://hepionpharma.com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL.pdf
HEPA AI-POWR
https://hepionpharma.com/ai-powr/
HEPA Tackling Chronic Liver Disease - CRV431 Mechanism of Action
https://www.youtube.com/watch?v=CE7es4l1avM
HEPA GLOBAL NASH CONFERENCE PRESENTATION:
https://12ewye24eigk3g5kwa2dxjzm-wpengine.netdna-ssl.com/wp-content/uploads/2021/04/4thGlobal_NASH_Congress_Draft_20Apr2021_FINAL-1.pdf
HEPA website
https://hepionpharma.com
Chairman of the Board, Gary Jacob, is not just a business guy, he's one hell of a biochemist, and you can bet he has a solid grasp of everything that's going on with Hepion.
He's a key player here!
His background goes way beyond what you ordinarily see on the BOD of little R&D biotechs. You might see those with his research background on Scientific Advisory Boards, but they wouldn't have a fraction of the business expertise he's got.
Hepion has the whole package, with this guy!!
Hepion Pharmaceuticals Welcomes Dr. Stephen Harrison to its Scientific Advisory Board
https://www.globenewswire.com/news-release/2019/08/07/1898563/0/en/Hepion-Pharmaceuticals-Welcomes-Dr-Stephen-Harrison-to-its-Scientific-Advisory-Board.html
Former Novo Nordisk Executive, Dr. Todd M. Hobbs, Joins Hepion Pharmaceuticals as Chief Medical Officer
Todd Hobbs coming to Hepion. It was published in December. Hobbs' primary focus has always been on diabetes, and I have said many times that there's a blockbuster reason for him leaving his position as Vice President, Chief Medical Officer at Novo Nordisk, a USD 190B global pharmaceutical behemoth, after nearly 17 years there, to come to tiny Hepion.
I believe we'll be hearing about CRV431 in the treatment of diabetes, as it has the highest known potency of any reported cyclophilin inhibitor known, by a wide margin...
https://www.biospace.com/article/releases/former-novo-nordisk-executive-dr-todd-m-hobbs-joins-hepion-pharmaceuticals-as-chief-medical-officer/
Nash Phase 2 & 3 Trials by companies in the space:
AKRO Akero Therapeutics 1.1 Billion Marketcap 240 Million in cash
MDGL Madrigal Pharmaceutical 1.7 Billion Marketcap 300 Million in cash
HEPA Hepion Pharmaceuticals 160 Million market cap 120 million in cash
Currently trading at $2.2 due to a public offering of 44.000.000 shares $2
According to analysts' consensus price target of $80.00, Hepion Pharmaceuticals has a forecasted upside of 3,503.6% from its current price of $2.22.
$HEPA
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