BioTuesdays

Hepion completes 75 mg CRV431 dosing, initiates 225 mg dosing in AMBITION trial

Hepion Pharmaceuticals

Hepion Pharmaceuticals (NASDAQ:HEPA) completed patient dosing in the 75 mg cohort of its Phase 2a ‘AMBITION’ clinical trial, which is evaluating CRV431 for the treatment of non-alcoholic steatohepatitis (NASH).

In addition, the company dosed the first patient in the 225 mg CRV431 cohort. All patients will now be observed for a 14-day follow-up period.

“We are delighted with our progress and anticipate that data from this trial will yield important insights that will be applied to our planned Phase 2b clinical trial, which is scheduled to begin in 2021,” Robert Foster, Ph.D., Hepion’s CEO, said in a statement.  

Stephen Harrison, M.D., Hepion’s consultant medical director, added, “Thus far, CRV431 appears well-tolerated in patients. Importantly, we will also be examining fibrosis using multiple non-invasive measures and looking for a dose-response relationship between the 75 mg and 225 mg dosing groups.”

The AMBITION study is evaluating CRV431, administered orally to F2 and F3 NASH patients, once daily for 28 days. Hepion’s clinical pharmacology group will examine certain biomarkers to determine CRV431’s activity in NASH and use AI-POWR to optimize the understanding of CRV431 in NASH.

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