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Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

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Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

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  • 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

 ­ Ref: PRNewswire | Image: PRNewswire

Click here to­ read the full press release 

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