Protagonist Reports Results of PN-943 in P-II (IDEAL) Study for the Treatment of Ulcerative Colitis
Shots:
- The P-II (IDEAL) study evaluating PN-943 (450/150mg, BID) vs PBO in 159 patients with UC for 12wks. The trial failed to meet the prespecified 1EPs, patients treated with a 150mg dose achieved 27.5% clinical remission with a delta of 13% over PBO in the mITT group & delta of 16% in the bio-naïve
- The therapy showed strong concordance across multiple parameters including histological remission & endoscopic improvement, safety analyses were similar b/w both groups, patients achieved clinical PoC & validation for PN-943
- The therapy showed a clear & consistent treatment effect across key EPs & dose-response was consistent with multiple other modalities. The company plans to initiate a P-III study of PN-943
Ref: Protagonist | Image: Protagonist
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