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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 two posters highlighting new data on the company’s lead clinical candidate, MET409, a farnesoid X receptor (FXR) agonist for the treatment of non-alcoholic steatohepatitis (NASH), will be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting Digital Experience™. The virtual meeting is taking place Nov. 13-16, 2020.
“We are pleased to report new pharmacokinetic and pharmacodynamic data from our MET409 Phase 1b proof-of-concept clinical trial in patients with NASH, a prevalent and potentially life-threatening condition for which there are no approved treatments available today,” said Hubert C. Chen, M.D., chief medical officer of Metacrine. “The findings demonstrated robust and sustained FXR activation, which we believe is key to optimizing therapeutic benefits. Combined with a favorable pharmacological and tolerability profile, these results further highlight the therapeutic potential of MET409 for patients with NASH. We look forward to presenting these data, which support the continued advancement of our FXR program, including both MET409 and our second clinical candidate, MET642.”
In addition, new data generated in collaboration with Dr. Mustafa R. Bashir, associate professor of Radiology and associate professor in the Department of Medicine, Gastroenterology, and colleagues at Duke University Medical Center, show that relative liver fat content (LFC) reduction after four weeks of treatment with MET409 was strongly predictive of LFC reduction at week 12 in the proof-of-concept study. “These findings suggest that early measurement of liver fat content may help guide the long-term treatment strategy with FXR agonists in NASH,” said Dr. Bashir.
Title: Dose-dependent changes in pharmacokinetic and pharmacodynamic profiles of MET409, a sustained FXR agonist, after 12 weeks of treatment in patients with NASH
Authors: E.J. Lawitz, K-J Lee, J. Shim-Lopez, J. Lee, H.C. Chen
Publication Number: 1669
Session Title: NAFLD and NASH: Therapeutics – Pharmacologic and Other
Key Findings: In a 12-week, randomized, double-blind, placebo-controlled study, 58 patients diagnosed with NASH were enrolled into three cohorts: 50 mg (n=19), 80 mg (n=20) and placebo (n=19). MET409 treatment resulted in dose-dependent decreases in serum levels of C4, a circulating biomarker of FXR target activity: 71-95% in trough levels at day 84 relative to baseline, and 78-96% in day 84 area-under-the-curve (AUC) relative to placebo (p
Title: Change in liver fat content at 4 weeks accurately predicts change in liver fat content at 12 weeks in non-alcoholic steatohepatitis patients treated with an FXR Agonist: Analysis from a 12-week, randomized, placebo-controlled study with MET409
Authors: H. Jiang, H.C. Chen, K.J. Lafata, M.R. Bashir
Publication Number: 1489
Session Title: NAFLD and NASH: Diagnostics and Biomarkers
Key Findings: As previously reported, MET409 significantly lowered LFC at week 12, with mean relative reductions of 55% (80 mg) and 38% (50 mg) vs. 6% in placebo (p. 11% in placebo (p
