Metacrine Inc. (NASDAQ: MTCR) has announced interim results from the phase 2a clinical study evaluating the safety and efficacy of MET642 in around 60 non-alcoholic steatohepatitis (NASH) patients following 16 weeks of treatment. MET6742 is a farnesoid X receptor agonist.
Metacrine reports Phase 2a MET642 study results
Also, the company has announced the prioritization of clinical development efforts and resources for the advancement of MET642 into a second phase study in inflammatory bowel disease starting in the first half of next year.
The Phase 2a study was a randomized, multi-center, placebo-controlled 16-week study that evaluated tolerability, safety, and pharmacological activity of MET642 as measured by liver fat content reduction with MRI-derived proton density fat fraction, liver enzymes changes, levels of low-density lipoprotein cholesterol, and pruritus incidence at 3 and 6 mg doses. Results showed that MET642 lowered liver fat content in the 4mg and 6mg cohorts relative to placebo. In addition, there was over 30% fat liver reduction in 47 patients that received MET642 in the 3mg cohort and 35% in the 6mg cohort.
MET642 demonstrated a considerable fat liver reduction
CEO Preston Klassen said, “We are encouraged by the MET642 interim clinical trial results, as this product candidate demonstrated meaningful liver fat reduction at 3 mg and a potentially class-leading tolerability profile for the treatment of NASH at both 3 mg and 6 mg. In this small interim analysis, the 6 mg cohort displayed a non-normal distribution in liver fat changes, as evidenced by differences between the mean and median results. Further clarification of the impact on liver fat at the 6 mg dose will require examination of the complete trial data set, which is anticipated in the first half of 2022. NASH is a complex and chronic disease that we believe will likely require combination regimes to most effectively treat patients. MET642 can potentially serve as an important part of these novel combination approaches.”