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- Shares of Protagonist Therapeutics (NASDAQ:PTGX) have lost 40.2% to $11.25 in aftermarket trading on Monday, after the company announced data from its phase 2 IDEAL study of its antagonist PN-943 in patients with ulcerative colitis, an inflammatory bowel disease that causes ulcers in the digestive tract.
- The IDEAL phase 2 study evaluated the safety and efficacy of PN-943 in 159 patients with moderate-to-severe ulcerative colitis. Two doses of PN-943 were assessed - a 450 mg twice daily dose and a 150 mg twice daily dose.
- The 450 mg twice daily dose did not meet the prespecified main goal of the study.
- In the twice daily 150 mg dose arm, PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across all key proxies including histological and endoscopic endpoints for efficacy.
- The company now has plans underway for a registrational phase 3 study based on the twice daily 150 mg dose of PN-943, pending regulatory guidance.