PN-943 Phase 2 IDEAL study shows 27.5% clinical remission at 150mg BID; 13% delta vs placebo

Protagonist Therapeutics, Inc

PN-943 150mg BID achieved 27.5% clinical remission vs 14.5% placebo (delta 13%, p=0.08); bio-naïve delta 16% (p=0.04).
Statistically significant histological remission (RHI≤6) at 37.2% vs 14.3% placebo (delta 23%, p=0.0107).
Endoscopic improvement: 43.1% vs 16.4% placebo (delta 26.7%, p=0.0023).
450mg BID showed no efficacy, consistent with bell-shaped dose-response observed for other α4β7 integrin antagonists.
No drug-related SAEs; safety profile similar to placebo; company plans to advance to Phase 3 registrational study.

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