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 (HEPA) announced that results from its Phase 2a AMBITION NASH trial will be available as an e-poster at the virtual Liver Meeting® 2021 from November 12-15, 2021. The trial, involving 43 patients, focused on CRV431 administration and successfully met all primary endpoints, demonstrating safety and pharmacokinetics. The trial's findings suggest the efficacy of CRV431 for treating NASH. Additionally, Hepion plans to utilize its AI-POWR™ platform to optimize patient response and explore further indications for CRV431.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that a study on its lead drug candidate, CRV431, will be presented as an e-poster at the Liver Meeting® 2021 from November 12-15. The research, led by Dr. Philippe Gallay, demonstrates that cyclophilin D knockout mice showed significantly lower tumor burden scores, suggesting that cyclophilin inhibition could be an effective treatment for hepatocellular carcinoma (HCC) linked to non-alcoholic steatohepatitis (NASH). CRV431, an AI-driven therapeutic, aims to reduce liver disease progression, showing potential in treating NASH.
Hepion Pharmaceuticals (NASDAQ:HEPA), a clinical-stage biopharmaceutical company specializing in AI-driven drug development, announced that its CMO, Dr. Todd Hobbs, will present at the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021, at 4:00 p.m. ET. This virtual presentation will be accessible live and archived on the company's website.
The lead drug candidate, CRV431, is in clinical development for the treatment of NASH and aims to improve outcomes in liver disease. Hepion's proprietary platform, AI-POWR™, is designed to identify optimal NASH patient responses.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced results from a Drug-Drug Interaction study of its lead drug candidate, CRV431, which targets cyclophilins to treat non-alcoholic steatohepatitis (NASH). The study showed that CRV431's pharmacokinetics were significantly enhanced when administered with ketoconazole, increasing Cmax five-fold and AUC0-24 nearly four-fold. Importantly, CRV431's interaction with midazolam was minimal, indicating its compatibility with other medications. The findings confirm CRV431's safety profile and potential for treating NASH patients with multiple drug therapies.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising results from its Phase 2a AMBITION trial of CRV431, aimed at treating non-alcoholic steatohepatitis (NASH). The trial showed significant reductions in biomarkers Pro-C3 and alanine aminotransferase (ALT), suggesting anti-inflammatory and antifibrotic effects. Advanced AI-POWR™ models indicated accurate predictions of patient responses to treatment. The study's success sets a foundation for the upcoming Phase 2b ASCEND-NASH trial, which aims to further evaluate CRV431's efficacy in NASH patients.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced it will release additional data from its Phase 2a AMBITION NASH clinical trial on September 13, 2021. The trial has already achieved all primary endpoints, and a conference call is scheduled for the same day to discuss the topline results and new data. The company's lead drug candidate, CRV431, is positioned to address non-alcoholic steatohepatitis (NASH) and liver disease. Hepion's proprietary AI platform, AI-POWR™, aims to enhance patient selection and drive clinical development for CRV431 and potentially other indications.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the postponement of its 2021 Annual Meeting of Stockholders originally scheduled for July 23, 2021, due to a lack of quorum. The Board of Directors will determine a new date and record date for the meeting. Hepion's lead drug candidate, CRV431, is under development for non-alcoholic steatohepatitis (NASH) and has shown promise in reducing liver fibrosis and hepatocellular carcinoma in preclinical studies. The company also introduced AI-POWR™, an AI platform aimed at improving patient response identification for CRV431.
Hepion Pharmaceuticals announced positive topline results from its Phase 2a AMBITION trial of CRV431, targeting non-alcoholic steatohepatitis (NASH). All primary endpoints were met, with no serious adverse events reported, indicating good safety and tolerability. The trial showed significant reductions in serum alanine aminotransferase (ALT) levels, a key NASH biomarker, suggesting a strong dose-response effect. Hepion plans to initiate a Phase 2b trial later in 2021, utilizing insights from the AMBITION trial to enhance CRV431’s development for NASH treatment.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the adjournment of its 2021 Annual Meeting of Stockholders originally scheduled for June 25, 2021, due to a lack of quorum. The meeting will now take place on July 23, 2021, at 9:00 a.m. ET. The record date for eligible voters remains April 29, 2021. Stockholders are encouraged to vote via Internet, mail, or in-person at the rescheduled meeting. Hepion’s lead candidate, CRV431, is in clinical development for treating NASH and is supported by their AI platform, AI-POWR™, aimed at optimizing patient response.
Hepion Pharmaceuticals (NASDAQ:HEPA) will join the Russell Microcap® Index on June 28, enhancing its visibility to institutional investors. This membership is seen as a milestone in Hepion's efforts to increase shareholder value through the clinical development of its lead candidate, CRV431, aimed at treating NASH and liver diseases. The Russell indexes are widely regarded benchmarks for $10.6 trillion in assets. Inclusion in these indexes could attract new investors and facilitate growth opportunities for the company.