Promising signs of clinical efficacy without increase in LDL cholesterol
SAN DIEGO, July 2, 2019 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, will present initial clinical data in nonalcoholic steatohepatitis (NASH) patients with MET409, a sustained non-bile acid FXR agonist. Ten NASH patients were dosed orally once-daily at 50 mg, and showed a 20% mean relative reduction in liver fat as measured by MRI-PDFF and improved liver function tests after only four weeks of treatment. MET409 was well-tolerated, with no serious adverse events, no adverse changes in LDL cholesterol and no incidence of pruritis. Further details will be provided during the poster presentation at the Paris NASH Meeting in Paris, France on July 11, 2019.
“This first clinical dataset, using one of our best-in-class FXR agonists is quite encouraging,” said Ken Song, MD, President and CEO of Metacrine. “A study to evaluate higher doses and longer duration of treatment is being initiated this summer and will provide more comprehensive data on overall safety, tolerability and impacts on overall liver health.”
NASH is a liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation and ballooning, resulting in progressive fibrosis that can lead to cirrhosis and eventual liver failure requiring liver transplant. There are currently no medications approved for the treatment of NASH. The proportion of liver transplants attributable to NASH has increased significantly in past years and is projected to be the leading cause of liver transplant by the end of 2020.
Metacrine has developed an extensive portfolio of oral FXR agonists that are taken once a day and have sustained activation of the target over 24 hours. MET409 is a representative non-bile acid sustained FXR agonist. The company is developing a “best of breed” FXR agonist from its library of over 2,500 compounds and plans to initiate human clinical studies in early 2020.
Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. Metacrine has purposefully designed a series of compounds to be optimized, next-generation FXR agonists. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.
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