Protagonist Weaves Positive Story From Mixed Phase II Data In Ulcerative Colitis

The company is pushing ahead into Phase III development with the lower dose of an oral drug for ulcerative colitis, even though a Phase II study missed the primary endpoint.

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Investors weren't sure what to make of Phase II data from Protagonist • Source: Alamy

Protagonist Therapeutics, Inc. sees a big potential commercial opportunity for its oral gut-restricted α4β7-integrin antagonist PN-943 in ulcerative colitis (UC) and is pushing ahead with the Phase III development of a low dose formula, despite mixed Phase II data that underwhelmed investors.

The Phase II IDEAL study, evaluating PN-943 at two doses twice a day (450 mg and 150 mg) in patients with moderate-to-severe UC, missed the primary endpoint – the proportion of subjects achieving clinical remission at Week 12 at the

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