Protagonist Therapeutics Topline Data from Phase 2 IDEAL Study of PN-943 (450 mg BID) Miss Primary Endpoint

Protagonist Therapeutics PTGX announced top-line results from the Phase 2 IDEAL clinical study evaluating PN-943 in patients with moderate-to-severe ulcerative colitis (UC).

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.

The results from the study underscores, PN-943 achieved strong concordance across all key proxies including histological and endoscopic endpoints for efficacy, in the twice daily 150 mg dose arm, While the 450 mg BID dose did not meet the prespecified primary endpoint

The company is planning for a registrational Phase 3 study anchored twice daily 150 mg dose of PN-943, anticipating regulatory guidance.

Scott Plevy, M.D., Executive Vice President and Therapeutic Head of Gastroenterology, said, “With the IDEAL study, we have demonstrated clinical proof-of-concept and validation for potential treatment of ulcerative colitis via oral, gut-restricted blockade of the alpha-4-beta-7-integrin pathway”.

Protagonist Therapeutics shares are trading down 37 percent at $11.90 during after hours.