2021-01-19 06:35:55 MTCR Metracrine
01/19/21 01/1906:35 01/19/2106:35 | Metracrine's MET642 granted Fast Track designation by FDAMetacrine announced that the FDA has granted Fast Track designation to MET642, the company's second farnesoid X receptor, or FXR agonist, for the treatment of non-alcoholic steatohepatitis, or NASH. "We are pleased to have received a second fast track designation for product candidates from our proprietary FXR platform and believe this further demonstrates the recognition of significant unmet needs in patients with NASH by regulatory authorities," said Hubert C. Chen, Chief Medical Officer of Metacrine. "Given our recently reported, favorable Phase 1 data for MET642, we are excited about its potential and look forward to advancing it into the Phase 2a study in the first half of this year." Metacrine recently completed a Phase 1 clinical trial of MET642 in healthy volunteers, in which MET642 was safe and generally well-tolerated and demonstrated a sustained pharmacokinetic profile and robust FXR target engagement after 14 days of daily oral dosing. |
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