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), a clinical stage biopharmaceutical firm, announced its participation in two virtual investor conferences this January. The H.C. Wainwright BioConnect 2021 Conference will feature a pre-recorded presentation available on Hepion's website from January 11, 2021, for 90 days. Additionally, the Biotech Showcase 2021 Digital will provide on-demand content for registered participants. Hepion’s lead candidate, CRV431, targets non-alcoholic steatohepatitis (NASH) and is developed using their proprietary AI-POWR™ platform to enhance treatment outcomes.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced positive top-line results from the low-dose cohort of its Phase 2a 'AMBITION' clinical trial for CRV431, aimed at treating non-alcoholic steatohepatitis (NASH). The trial showed CRV431 to be generally safe and well tolerated, with significant reductions in key liver biomarkers, ALT and AST, observed over 28 days. The study continues with a higher dosage of 225 mg, with the completion of dosing expected in Q1 2021. The company will further analyze data to enhance the design of its Phase 2b trial, anticipated to start mid-2021.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that the independent Data Safety Monitoring Board (DSMB) has confirmed the safety and tolerability of CRV431 in its Phase 2a AMBITION trial for NASH patients. The DSMB approved the continuation of the trial after two interim analyses and recommended moving to the final dosing cohort of 225 mg, expected to be completed in early 2021. The AMBITION trial, the first placebo-controlled study for CRV431, targets patients with moderate-to-severe fibrosis, aiming to demonstrate the drug's efficacy in reducing liver fibrosis.
Hepion Pharmaceuticals received FDA clearance for its CRV431 investigational new drug application aimed at treating COVID-19. This follows promising preclinical results indicating reduced SARS-CoV-1 infectious virus production and lung inflammation. CRV431, a cyclophilin inhibitor, may address both viral infection and acute respiratory distress syndrome (ARDS). The company aims to initiate a Phase 2 study and seek partnerships for further development. Hepion remains focused on its primary indication, NASH, while exploring CRV431's broad therapeutic potential.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the successful completion of patient dosing in the 75 mg cohort of its Phase 2a AMBITION clinical trial for non-alcoholic steatohepatitis (NASH) and began dosing the first patient in the 225 mg cohort. The trial, involving 18 patients per dosing group, will assess safety, tolerability, and pharmacokinetics over 28 days. With a focus on identifying biomarkers for NASH, Hepion is utilizing its AI-POWR platform to enhance trial insights. The company anticipates valuable data to inform the upcoming Phase 2b trial in 2021.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising findings regarding CRV431, its lead drug candidate for treating non-alcoholic steatohepatitis (NASH). A study revealed that CRV431 reduced the formation of procoagulant platelets by up to 49%, potentially lowering the risk of ischemic strokes in patients with liver disease. While no significant effect on platelet aggregation was noted, these findings support CRV431's role in addressing the cardiovascular risks associated with NASH. The therapeutic shows safety and efficacy in previous clinical trials, indicating a multi-faceted approach to treating liver disease.
Hepion Pharmaceuticals (NASDAQ:HEPA) has completed its underwritten public offering of common stock, raising approximately $34.5 million in gross proceeds, with net proceeds around $31.7 million after expenses. The funds will primarily support research and development, along with general corporate purposes. The offering followed a registration statement declared effective on November 24, 2020. Hepion's lead candidate, CRV431, is under Phase 2 studies for treating non-alcoholic steatohepatitis (NASH).
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced a public offering of 20 million shares of common stock priced at $1.50 per share, aiming to raise approximately $30 million before expenses. The offering includes a 45-day option for underwriters to purchase an additional 3 million shares. Proceeds will fund research and development, working capital, and corporate purposes. The offering is set to close on November 30, 2020, subject to customary conditions. This is part of the company's focus on therapeutic drugs for liver diseases, particularly NASH.
The independent Data Safety Monitoring Board (DSMB) has approved the continuation of Hepion Pharmaceuticals' Phase 2a AMBITION clinical trial for CRV431 in NASH patients. This approval follows the successful review of the 75 mg dose cohort, which showed no safety concerns and clinically significant reductions in liver enzymes ALT and AST. The trial will now advance to a 225 mg dose cohort. Approximately 17 million people in the U.S. suffer from NASH, leading to a significant unmet medical need.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced its participation in the Alliance Global Partners' Virtual Healthcare Symposium on November 19, 2020. This event will feature a series of one-on-one meetings with management. The company is focused on developing therapies for liver diseases, particularly non-alcoholic steatohepatitis (NASH). Their lead candidate, CRV431, has shown promise in reducing liver fibrosis and tumor burden in preclinical studies, with potential antiviral effects against HBV, HCV, and HDV.