“NASH is a multifactorial liver disease associated with a number of co-morbidities, including type 2 diabetes,” said
SGLT2 inhibitors, such as empagliflozin, are once-daily, oral anti-diabetic medications that are increasingly viewed as a paradigm-shifting therapeutic class for T2DM. In addition to beneficial effects on metabolic control and cardio-renal protection, SGLT2 inhibitors have demonstrated positive effects on liver fat reduction. In a proof-of-concept trial in patients with NASH and T2DM, empagliflozin (10 mg) achieved approximately 30% relative liver fat reduction after 20 weeks of treatment. SGLT2 inhibitors therefore have the potential to complement the liver-targeting therapeutic effects of FXR agonism on hepatic steatosis, inflammation and fibrosis.
“We are pleased to begin this trial, given the meaningful impact this combination could demonstrate in patients affected by these challenging and often overlapping conditions,” said
The Phase 2a clinical trial is a 12-week, randomized, placebo-controlled, multi-center trial evaluating the safety, tolerability and pharmacological activity (as measured by reductions in liver fat content with magnetic resonance imaging-derived proton density fat fraction) of MET409 in combination with empagliflozin in patients with T2DM and NASH. Eligible patients will be randomized into one of four cohorts: MET409 (50 mg), MET409 (50 mg) plus empagliflozin (10 mg), placebo alone or placebo plus empagliflozin (10 mg). Each trial drug will be given once-daily by oral administration. The trial will enroll up to 120 patients in
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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. Forward-looking statements contained in this press release include statements regarding the therapeutic potential of MET409; statements regarding Metacrine’s timelines; the differentiated nature of Metacrine’s FXR program; plans underlying Metacrine’s clinical trials; plans for advancing the clinical development of Metacrine’s FXR program; the potential for its FXR product candidates to be long-term therapies for NASH; the potential for its FXR product candidates to be used in combination therapies; and the potential for its FXR product candidates to be therapies for patients with both NASH and T2DM. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies and uncertainties related to the regulatory approval path for the NASH indication. Words such as “may,” “could,” “will,” “encourage,” “expect,” “plan,” “aim,” “anticipate,” “estimate,” “intend,” “potential,” “prepare” 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
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