Metacrine Announces FDA Fast Track Designation for MET642 as a Treatment of NASH

Metacrine, Inc. (Nasdaq: MTCR), a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies for patients with liver and gastrointestinal diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to MET642, the company’s second farnesoid X receptor (FXR) agonist, for the treatment of non-alcoholic steatohepatitis (NASH).

“We are pleased to have received a second fast track designation for product candidates from our proprietary FXR platform and believe this further demonstrates the recognition of significant unmet needs in patients with NASH by regulatory authorities,” said Hubert C. Chen, M.D., chief medical officer of Metacrine. “Given our recently reported, favorable Phase 1 data for MET642, we are excited about its potential and look forward to advancing it into the Phase 2a study in the first half of this year.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs designed to treat serious diseases or conditions that have the potential to fill an unmet medical need for such diseases or conditions. Through the Fast Track designation, the company may be eligible to submit sections of its New Drug Application on a rolling basis, and there are opportunities for more frequent interactions and written communications with the FDA around the drug’s development plan. A Fast Track-designated product may also be eligible for accelerated approval and priority review if the criteria for those programs are satisfied.

Metacrine recently completed a Phase 1 clinical trial of MET642 in healthy volunteers, in which MET642 was safe and generally well-tolerated and demonstrated a sustained pharmacokinetic profile and robust FXR target engagement after 14 days of daily oral dosing. Importantly, pruritus and LDL-cholesterol increases were not seen at any dose level. The company plans to further evaluate MET642 in a Phase 2a, 16-week, randomized, placebo-controlled trial in patients with NASH, which is expected to begin in the first half of 2021.

About Metacrine
Metacrine, Inc. (Nasdaq: MTCR) is a clinical-stage biopharmaceutical company building a differentiated pipeline of therapies to treat liver and gastrointestinal (GI) diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated a differentiated and improved therapeutic profile in clinical trials. The company’s two product candidates, MET409 and MET642, are currently being investigated in clinical trials as potential new treatments for non-alcoholic steatohepatitis (NASH). MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being advanced into a 16-week monotherapy trial in patients with NASH.

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