- Protagonist Therapeutics Inc PTGX announced topline results from the Phase 2 IDEAL study of PN-943 in moderate-to-severe ulcerative colitis (UC) patients.
- 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.
- While the 450 mg BID dose did not meet the prespecified primary endpoint, the 150 mg dose achieved 27.5% clinical remission with a delta of 13% versus the placebo (p=0.08) in the modified Intent to Treat (mITT) group and a delta of 16% (p=0.04) in the bio-naïve group.
- Also see: FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer.
- In addition, the 150 mg BID data showed strong concordance across multiple parameters, including statistically significant histological remission and endoscopic improvement.
- Safety analysis was similar for the 150 mg BID dose versus the placebo group.
- Protagonist plans are underway for a registrational Phase 3 study anchored around twice daily 150 mg dose of PN-943, pending regulatory guidance.
- Price Action: PTGX shares are down 46.8% at $10 during the market session on the last check Tuesday.
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