Metacrine (MTCR) Commences Phase 2a Trial of MET642 for Treatment of Patients with NASH

March 9, 2021 6:36 AM EST

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Metacrine, Inc. (NASDAQ: MTCR) today announced that the first patient has been treated in its Phase 2a trial of MET642, a potent, sustained, non-bile acid farnesoid x-receptor (FXR) agonist, for the treatment of patients with non-alcoholic steatohepatitis (NASH).

“NASH is a devastating disease, for which an optimized FXR agonist could play a foundational role in the treatment paradigm,” said Hubert C. Chen, M.D., chief medical officer of Metacrine. “MET642 has demonstrated an encouraging profile - including sustained pharmacodynamic effects without pruritus or low-density lipoprotein cholesterol increase - after 14 days of daily oral dosing in our Phase 1 study in healthy volunteers. We are pleased to start this important proof-of-concept study in patients with NASH and look forward to sharing interim results in the fourth quarter of 2021.”

Metacrine has developed a proprietary FXR platform utilizing a unique chemical scaffold, which has demonstrated a clinically differentiated and improved therapeutic profile. The company’s lead FXR clinical candidate, MET409, has successfully completed a 12-week trial in patients with NASH. MET642 is derived from the same chemical scaffold as MET409, with comparable FXR target engagement and pharmacology in preclinical studies, while demonstrating increased potency and differentiated pharmaceutical properties relative to MET409.

The Phase 2a clinical trial is a 16-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity (as measured by liver fat reduction) of MET642 (3 mg and 6 mg) vs placebo. An interim analysis is planned in the fourth quarter of 2021, after approximately 60 patients have completed 16 weeks of treatment. Topline trial results of up to 180 patients are expected to be reported in the first half of 2022.

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