Gannex Reports First Patient Dosing in P-II Clinical Trial of ASC42 for the Treatment of Primary Biliary Cholangitis
Shots:
- The first patient has been dosed in the P-II clinical trial to evaluate ASC42 (5/10/15 mg) vs PBO in a ratio (1:1:1:1) in 100 patients with PBC who have an inadequate response to or are unable to tolerate UDCA for 12wks. and the trial is expected to be completed at the end of 2022
- In the P-I trial, ASC42 showed no pruritus & FXR target engagement biomarker FGF19 increased by 1,780% on Day 14 of treatment with a 15 mg dose, mean LDL-C values remained within the normal range
- The company plans to initiate the P-III trial after the discussion with the NMPA regarding drug registration related matters such as CMC & toxicology studies in the US, China & EU, following the completion of the P-II trial
Ref: PRNewswire | Image: Crunchbase
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