Protagonist Therapeutics announced topline results from the Phase 2 IDEAL study evaluating PN-943 in patients with moderate-to-severe ulcerative colitis (UC). Summary of Key Results: IDEAL is a randomized, double-blinded, placebo-controlled, multicenter Phase 2 study to evaluate the safety and efficacy of PN-943, an oral, gut-restricted, alpha-4-beta-7-integrin antagonist. 159 patients with moderate-to-severe active UC were randomized to either twice daily (BID) with 450 mg or 150 mg PN-943, or placebo, for 12 weeks and analyzed for outcome measures.

While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved a placebo versus treatment delta of 13% (p=0.08) in the modified Intent to Treat (mITT) group, and a delta of 16% (p=0.04) in the bio-naïve group. In addition, the 150 mg BID data showed strong concordance across multiple parameters including statistically significant histological remission and endoscopic improvement. PN-943 150 mg BID dose forms the basis for a Phase 3 registrational program: 27.5% clinical remission vs 14.5% in placebo (delta 13%, p=0.08) for mITT analysis; 16% delta in BIO-naïve population (p=0.04); Strong concordance with efficacy across multiple key secondary endpoints with statistically significant differences in histologic remission/improvement and endoscopic improvement; and Safety analysis similar for the 150 mg BID dose versus the placebo group.