Hepion Pharmaceuticals Inc (HEPA)

[Crusader]

Positive SEC filing today by HEPA:


“...EDISON, N.J.,?December 10, 2020 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA, “Hepion”), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced that, in addition to completing patient dosing in the 75 mg CRV431 cohort of its Phase 2a ‘AMBITION’ clinical trial, it has dosed the first NASH patient in the 225 mg CRV431 dosing cohort.

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. Hepion will also conduct Fibroscans and examine a multitude of candidate biomarkers of NASH resolution and CRV431 efficacy including Pro-C3, Enhanced Liver Fibrosis (ELF) markers, collagens, matrix metalloproteinases, transcriptomics, liver transaminases, and full-scale lipidomic and genomic signatures. Identification of biomarkers will be facilitated by Hepion’s proprietary, machine-learning platform, AI-POWR™.

“We are pleased to complete dosing of all NASH patients in our 75 mg CRV431 cohort,” stated Dr. Robert Foster, Hepion’s CEO. “All patients will now be observed for a 14-day follow-up period, which is scheduled to be completed by December 16, 2020. In parallel with the completion of this dosing cohort, we have now dosed the first NASH patient in the 225 mg cohort. 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.”


https://www.sec.gov/Archives/edgar/data/1583771/000110465920134049/tm2038218d1_ex99-1.htm

“I continue to look forward to seeing the read-out from the 75 mg dosing cohort,” commented Dr. Stephen Harrison, Hepion's Consultant Medical Director. “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.”