Hepion Pharma cleared to advance final dosing cohort in NASH trial

 

• Hepion Pharmaceuticals (NASDAQ:HEPA) announces that an independent Data Safety Monitoring Board has approved the continuation of the company's Phase 2a clinical trial for its lead asset CRV431 in NASH (non-alcoholic steatohepatitis) patients with moderate-to-severe fibrosis.
• The two evaluations conducted half-way through the first dosing cohort and at its completion have not found any safety or tolerability concerns with CRV431, the company said in a statement.
• Commenting on the second review by the DSMB of the AMBITION trial, Dr. Robert Foster, Hepion's CEO, says: "Now that we have completed dosing in our 75 mg cohort, we are enrolling our final dosing cohort of 225 mg.”
• The dosing of all patients, likely to complete in Q1 2021, will be followed by final data read-out for both dosing cohorts, thereafter according to Dr. Foster, who added that the ‘top line preliminary data from our 75 mg dosing group is imminent.’
• CRV431 is a pan-cyclophilin inhibitor that inhibits multiple forms of cyclophilins, causing multiple biological effects such as inflammation and fibrosis. NASH, where the formation of liver fibrosis can lead to death, has no approved therapies and affects 17 million people in the U.S., becoming a leading cause of liver transplantation.
• https://seekingalpha.com/news/3647673-hepion-pharma-cleared-to-advance-final-dosing-cohort-in-nash-trial