Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis
Shots:
- The P-II AMBER2 study assessing the efficacy and safety of SHR0302 (8mg qd/4mg bid/4mg qd) vs PBO in 164 adults with moderate to severe UC across 84 sites in China, US, and EU. The AMBER2 study consisted of an 8wks. induction period, followed by an 8wks. extension period
- The study met its 1EPs i.e. percentage of patients who achieved a clinical response per the 9-point Mayo Score (46.3%/46.3%/43.9% vs 26.8%) @8wks., improvement in patients (22%/24.4%/24.4 vs 4.9%) respectively
- SHR0302 is a potent and highly selective JAK1 inhibitor. The company expects to initiate the P-III program in 2021
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