Metacrine Achieves Enrollment Target for MET642 Phase 2a Trial Interim Analysis
Metacrine (NASDAQ:MTCR) announced the enrollment of 60 patients in its Phase 2a trial for MET642, aimed at treating NASH. Interim data is expected to be released in Q4 2021, following 16 weeks of treatment. The study will ultimately include 180 patients, with full topline results anticipated in H1 2022. The trial evaluates the safety and efficacy of MET642, a farnesoid X receptor agonist, which has shown promise based on earlier research.
- Enrollment of first 60 patients in MET642 Phase 2a trial indicates progress in clinical development.
- Anticipation of interim data in Q4 2021 may boost market confidence.
- No concrete data from trial released yet, creating uncertainty around product efficacy.
- Potential delays in full topline results expected in H1 2022 could affect investor sentiment.
- Interim data from the first 60 patients with NASH on track to be reported in the fourth quarter of 2021
- Enrollment continuing for up to 180 patients, with full topline results expected to be reported in the first half of 2022
SAN DIEGO, May 18, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced it has enrolled the first 60 patients in its MET642 Phase 2a trial. The Company remains on track to report interim results in the fourth quarter of 2021 after these patients have completed 16 weeks of treatment.
“The promise of an optimized FXR agonist has motivated investigators, and most importantly patients, to participate in our study,” said Hubert C. Chen, M.D., chief medical officer, Metacrine. “We are grateful for their enthusiasm and support in reaching this important milestone, as well as for the hard work of our clinical operations team in a challenging Covid-19 environment.”
The Phase 2a study (NCT04773964) 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). Full topline trial results of up to 180 patients are expected to be reported in the first half of 2022.
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; statements regarding the therapeutic potential of MET409 and MET642; the differentiated nature of Metacrine’s FXR program; . 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 18, 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 are the key milestones for Metacrine's MET642 Phase 2a trial?
What is the purpose of the MET642 trial for treating NASH?
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What is the significance of the FXR agonist in NASH treatment?
