Metacrine Achieves Full Enrollment for MET642 Phase 2a Trial in Patients With Nash

Rhea-AI Summary

Metacrine, Inc. (NASDAQ:MTCR) has successfully completed patient enrollment for its Phase 2a trial of MET642, an FXR agonist targeting non-alcoholic steatohepatitis (NASH), surpassing its goal of 180 participants. Interim results from the first 60 patients are expected in Q4 2021, with topline results for all patients anticipated in H1 2022. The trial evaluates safety and efficacy via MRI-PDFF and other metrics at 3 mg and 6 mg doses. The company aims to proceed with further studies in NASH and inflammatory bowel disease following the interim results.

Positive

• Exceeded enrollment target of 180 patients for Phase 2a trial.
• Interim data from first 60 patients expected in Q4 2021.
• Topline results for all patients anticipated in H1 2022.

Negative

• None.

• Exceeded enrollment target of 180 total patients
• Interim data from the first 60 patients expected early in the fourth quarter of 2021
• Topline MET642 trial results from all patients are anticipated in the first half of 2022
  

SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced that it has completed enrollment for its Phase 2a trial evaluating MET642, an optimized farnesoid X receptor (FXR) agonist, in patients with non-alcoholic steatohepatitis (NASH). The Company plans to report interim data from the first 60 patients early in the fourth quarter of 2021.

“As a potentially best-in-class FXR agonist, MET642 has motivated investigators, and most importantly patients, to participate in our study despite a challenging Covid-19 environment,” said Hubert C. Chen, M.D., chief medical officer, Metacrine. “Thanks to the diligent work of our clinical operations team and partners, we are just a few weeks away from announcing the MET642 interim results, which would enable initiation of a liver biopsy study in NASH and a proof-of-concept study in IBD in the first half of 2022.”

The Phase 2a study (NCT04773964) is a 16-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity of MET642, as measured by reductions in liver fat content with magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), changes in liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels and incidence of pruritis, at 3 mg and 6 mg dose levels.

About Metacrine

Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat liver and gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an 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 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 evaluated in a 16-week monotherapy trial in patients with NASH. To learn more, visit www.metacrine.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements about the design, progress, timing, scope and results of clinical trials; the anticipated timing of disclosure of results of clinical trials; plans for initiating future clinical trials and studies; statements regarding the therapeutic potential of MET409 and MET642; the differentiated nature of Metacrine’s FXR program; plans for advancing the clinical development of Metacrine’s FXR program; the potential best-in-class nature of Metacrine’s FXR program; and the potential for its FXR product candidates to be long-term therapies for NASH and IBD. Words such as “may,” “will,” “expect,” “plan,” “aim,” “projected,” “likely,” ”anticipate,” “estimate,” “intend,” “potential,” “prepare,” “perceived,” “believes” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Metacrine’s expectations and assumptions that may never materialize or prove to be incorrect. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks and uncertainties regarding regulatory approvals for MET409 or MET642; potential delays in initiating, enrolling or completing any clinical trials; potential adverse side effects or other safety risks associated with Metacrine’s product candidates; competition from third parties that are developing products for similar uses; and Metacrine’s ability to obtain, maintain and protect its intellectual property. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Metacrine’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2021, and in Metacrine’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as required by law, Metacrine assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

FAQ

What is the purpose of the MET642 trial by Metacrine?

The MET642 trial aims to evaluate the safety and efficacy of the FXR agonist MET642 in patients with non-alcoholic steatohepatitis (NASH).

When will interim results from the MET642 trial be released?

Interim results from the first 60 patients in the MET642 trial are expected to be announced in the early part of Q4 2021.

What are the expected topline results for the MET642 trial?

Topline results for all patients in the MET642 trial are anticipated in the first half of 2022.

What are the implications of the MET642 trial results?

The results may enable Metacrine to initiate further studies in NASH and a proof-of-concept study for inflammatory bowel disease (IBD).

What does FXR agonist mean in the context of MET642?

FXR agonist refers to a compound that activates the farnesoid X receptor, which plays a crucial role in regulating bile acid, glucose, and lipid metabolism, making it relevant for treating liver diseases.