The trial was meant to assess the efficacy and safety of PN-943 in patients with moderate-to-severe ulcerative colitis with two doses set at 150 milligrams and 450 milligrams.
Scott Plevy, therapeutic head of gastroenterology at Protagonist, said in a statement that the lower-dose arm offered "consistent evidence of clinical efficacy and safety." The company said PN-943 150 mg achieved 27.5% clinical remission and that plans for a registrational Phase 3 study based on twice-daily 150-mg dose of PN-943 are in progress.
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