- 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.
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.
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.
Investor & Media Contact Steve Kunszabo Metacrine, Inc. +1 (858) 369-7892 firstname.lastname@example.org