SAN DIEGO, April 3, 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 data showing MET409, a potent, systemic and sustained non-bile acid farnesoid X receptor (FXR) agonist, is safe and well tolerated in a Phase 1 study of healthy subjects. The poster presentation will take place at EASL being held in Vienna, Austria on April 13, 2019.
The Phase 1 study was a 2-part single ascending and multiple ascending design whereby certain subjects received daily doses of MET409 for 14 days at dose levels ranging from 20mg to 150mg. MET409 was found to be safe and well-tolerated with no significant adverse events reported. Importantly, MET409 did not show an increase in LDL cholesterol levels or any pruritus at projected therapeutic doses. In addition, MET409 exhibited a sustained profile based on both drug levels as well as FXR target engagement throughout 24 hours.
“We are highly encouraged by the findings from our Phase 1 study as it shows the sustained target engagement which we view as essential for optimal efficacy and also a differentiated safety profile,” said Ken Song, MD, President and CEO of Metacrine. “Our FXR program has been purposefully designed to generate the best-in-class FXR agonists for NASH and the initial MET409 data is supportive of our approach.”
NASH is a liver disease that exists along a continuum of progressive liver deterioration and is characterized by fatty deposits, inflammation and cellular damage. NASH is expected to be the #1 reason for liver transplant by the year 2020. Targeting FXR, a nuclear hormone receptor, represents a clinically validated and effective approach to treating NASH with the added benefit of improving fibrosis.
MET409 is currently being evaluated in a clinical study in NASH patients with initial data expected this year. In addition, Metacrine continues to advance other FXR agonists beyond MET409 into development.
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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