Hepion Pharmaceuticals Inc. (NASDAQ:HEPA) has announced that besides completion of patient dosing in the Phase 2a 75 mg CRV431 cohort of the “AMBITION” clinical study it has also dosed the first NASH subject in the 225 mg CRV431 cohort.
Assessing the safety and tolerability of CRV431
The company designed the open-label Phase 2a AMBITION trial to assess safety, pharmacokinetics, tolerability, and biomarker efficacy analyses of the 225 mg and 75 mg CRV431 doses in F2 and F3 NASH patients for four weeks. Hepion plans to conduct Fibroscans and assess the extent of candidate biomarkers of NASH resolution as well as CRV431 efficacy which includes Enhanced Liver Fibrosis (ELF) biomarkers, Pro-C3, Matric metalloproteinase, collagens, liver transaminases, transcriptomics, and lipidomic and genomic signatures. The company’s AI-POWR™ machine learning platform will facilitate biomarkers identification.
Dr. Robert Foster the company’s CEO stated that they are delighted to complete the dosing of the Nash patients in the 75 mg CRV431 cohort. He added that the patients were observed in a follow-up period of 14 days that ended on December 16, 2020. Foster said that besides the completion of the dosing in the cohort they are pleased to dose the first patients in the 225 mg CRV431 cohort. He said that everything is going as planned and the company expects data from the study to provide significant insights that will be vital in the planned Phase 2b clinical study that will begin in 2021.
CRV431 well tolerated in clinical trials
Hepion’s Consultant Medical Director Stephen Harrison said that he is looking forward to a 75 mg dosing cohort data readout. Stephen said that so far CRV431 has demonstrated good tolerability in patients. Most importantly the company will continue evaluating fibrosis through multiple non-invasive measures and also look for a dose-response connection between the 75 mg and 225 mg CRV431 dosing cohorts.
CRV431 which the company is evaluating is a strong cyclophilins inhibitor and has demonstrated considerable potential as a treatment for liver diseases. It has demonstrated that it can minimize liver fibrosis as well as hepatocellular carcinoma burden.