Shots:
- Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis
- Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP, with 49.57% vs 34.82% attaining ≥1-grade inflammation improvement (Scheuer score) without fibrosis progression; data to be published & shared in the future
- Additionally, Gyre plans to file an NDA with China’s NMPA & an IND application to the US FDA in Q3’25, respectively & aims to initiate P-II trial for MASH-associated fibrosis in H2’25, subject to IND clearance
Ref: Globenewswire | Image: Gyre Therapeutics| Press Release
Related News:- Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)
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