Hepion Pharmaceuticals reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced two poster presentations for its lead drug candidate, rencofilstat, at the Liver Meeting® 2022 from Nov 4-8. The presentations focus on the drug's effects on NASH and liver fibrosis. The first poster discusses rencofilstat's impact on multi-omics in NASH subjects, while the second highlights a study showing cyclophilin B knockout's role in liver fibrosis prevention. CEO Robert Foster emphasized AI's role in enhancing trial design and patient identification. Rencofilstat is in Phase 2b trials and has received Fast Track and Orphan Drug designations from the FDA.
Hepion Pharmaceuticals announced that the Phase 2a study of its drug candidate rencofilstat for non-alcoholic steatohepatitis (NASH) successfully met its primary endpoints focusing on safety and pharmacokinetics. The study demonstrated significant reductions in ALT, ProC3, and C6M biomarkers, indicating potential antifibrotic effects. Enrollment for the Phase 2b trial, ‘ASCEND-NASH’, has begun with 336 subjects. The findings underscore the drug's potential effectiveness and support its progression toward clinical development.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) has announced the publication of a peer-reviewed study in Clinical Pharmacology in Drug Development, which investigates food's impact on rencofilstat's bioavailability. The Phase 1 trial demonstrated that a high-fat meal enhances the absorption of rencofilstat without causing toxicity, suggesting the potential for improved efficacy in NASH and HCC patients. This flexibility in administration aligns with real-world conditions. Rencofilstat has received Fast Track and Orphan Drug designations from the FDA for its applications in NASH and HCC.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) announced that CEO Robert Foster will present at the ThinkEquity Conference in New York City on October 26, 2022, at 1:30 p.m. ET. The presentation will be live-streamed and archived on their website. Hepion's lead drug candidate, rencofilstat, targets non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). It has received Fast Track and Orphan Drug designations from the FDA, demonstrating its potential in treating liver diseases. The company utilizes its proprietary AI-POWR™ platform to enhance drug response insights.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its Chief Medical Officer, Todd Hobbs, MD, will participate in the "Novel Targets in Oncology: Risk vs. Reward" panel at the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022. Dr. Hobbs will discuss the Phase 2 clinical trial of rencofilstat, targeted at treating hepatocellular carcinoma (HCC). Rencofilstat has shown promise in reducing liver fibrosis and HCC tumor burden, and has received Fast Track and Orphan Drug designations from the FDA for its development in treating NASH and HCC, respectively.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced its collaboration with London's Institute of Hepatology to present new findings on rencofilstat at the ISBRA and ESBRA joint meeting in Cracow, Poland, from September 17-20, 2022. The study highlights rencofilstat's effectiveness against Alcohol-associated Liver Disease (ALD) by targeting cyclophilins, which are implicated in liver damage. Results showed significant reductions in fibrosis markers and improved cytokine profiles in liver tissue models. CEO Dr. Robert Foster emphasized rencofilstat's potential in treating ALD-induced fibrosis.
Hepion Pharmaceuticals has initiated a Phase 2 clinical trial for rencofilstat, targeting non-alcoholic steatohepatitis (NASH). The ALTITUDE-NASH study will assess 60 adult subjects over four months, with doses of 75, 150, or 225 mg. The trial's goal is to evaluate hepatic function using HepQuant's SHUNT test and other NASH biomarkers. This collaboration with HepQuant and Summit Clinical Research highlights the pressing need for effective NASH treatments, as the disease poses significant health risks without FDA-approved therapies.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) will participate in the H.C. Wainwright 24th Annual Global Investment Conference, with a pre-recorded presentation available on demand for attendees from September 12, 2022. The company is focused on developing rencofilstat, an AI-driven therapeutic for chronic liver diseases, including non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). Rencofilstat has received FDA Fast Track and Orphan Drug designations, demonstrating its potential in addressing liver disease and improving patient outcomes.
Hepion Pharmaceuticals has announced the screening of the first subject in its ASCEND-NASH clinical trial, aimed at studying rencofilstat for treating non-alcoholic steatohepatitis (NASH). The Phase 2b trial will involve 336 subjects over one year, focusing on F2/F3 fibrosis levels, with a target for 60% F3 subjects. Rencofilstat aims to improve fibrosis and steatosis scores. The trial will also employ AI-POWR™ technology to identify patients likely to respond positively. Hepion received FDA Fast Track designation for rencofilstat in November 2021, facilitating smoother transitions through clinical phases.
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced the adjournment of its 2022 annual meeting to August 5, 2022, at 9:00 a.m. ET regarding Proposal 4 for an authorized share increase. The record date for voting remains April 26, 2022. Proxies representing about 60% of shares have been submitted, allowing for a quorum. The Board believes that approving this proposal will provide flexibility for future financings and other purposes. Shareholders are encouraged to vote by August 4, 2022, at 11:59 p.m. ET.