Overview

• The 50 mg dose achieved the FDA primary endpoint of clinical remission at Week 8 in both ABTECT-1 and ABTECT-2, with pooled placebo‑adjusted remission of 16.4% and individual trial differences of 19.3% and 13.4%, while all key secondary endpoints were met.
• Pooled analyses reported clinically meaningful benefits regardless of prior inadequate response to advanced therapies, including a 28% placebo‑adjusted clinical response in patients without AT‑IR and a 29% difference in those with four or more prior AT‑IR.
• Patients with prior JAK inhibitor failure showed a 34% placebo‑adjusted improvement in clinical response with 50 mg, and efficacy extended to endoscopic and histologic endpoints across subgroups.
• No Week-8 signal was observed for serious, severe, or opportunistic infections or malignancies; the most common adverse events were headache (6% placebo, 16% at 25 mg, 24.1% at 50 mg) and nausea (1.3%, 5.0%, 7.2%).
• Across the two induction trials, 1,272 participants were enrolled, about 47% had prior inadequate response to advanced therapies and roughly 21% had failed JAK inhibitors, with additional subgroup findings presented as late‑breaking data at UEG and an investor call scheduled for 9 a.m. ET on Oct. 6.