Expert Interview
Analyzing Phase 3 ABTECT Induction Trial Results for Obefazimod in Moderate to Severely Active Ulcerative Colitis from Abivax
Ticker(s): AAVXFA gastroenterologist and inflammatory bowel disease (IBD) specialist experienced in clinical trials for ulcerative colitis, with expertise in biologics and novel oral therapies, and familiarity with treatment strategies for patients who have failed prior advanced therapies including JAK inhibitors.
The 50 mg once-daily dose of obefazimod achieved a pooled placebo-adjusted clinical remission rate of 16.4% (p<0.0001) at Week 8 across ABTECT-1 and ABTECT-2. How meaningful is this remission rate compared to current advanced therapies used in moderate to severely active UC?
Added By: slingshot_insightsABTECT-1 reported a 19.3% placebo-adjusted remission rate while ABTECT-2 showed 13.4%. What factors could explain the variance between these two trials, and does this impact the overall interpretation of efficacy?
Added By: slingshot_insightsAll key secondary endpoints, including endoscopic improvement and clinical response, were met with high statistical significance. How do these secondary outcomes strengthen confidence in obefazimod’s therapeutic potential?
Added By: slingshot_insightsNearly half of the study population had inadequate response to prior advanced therapies, including the largest cohort of JAK inhibitor-experienced patients in a Phase 3 UC trial. How do the results inform treatment strategies for these difficult-to-treat subgroups?
Added By: slingshot_insightsThe 25 mg dose met clinical remission in ABTECT-1 but not in ABTECT-2, while both doses showed strong clinical response rates. Do these findings suggest potential for dose optimization or personalized dosing in clinical practice?
Added By: slingshot_insightsObefazimod demonstrated favorable tolerability with no new safety signals observed. How does this safety profile position obefazimod for long-term maintenance therapy compared to existing oral and biologic treatments?
Added By: slingshot_insightsWith 678 responders now enrolled in the 44-week maintenance trial and regulatory submissions planned for late 2026, what will be the most critical outcomes to watch for that could influence approval and adoption?
Added By: slingshot_insightsAs a first-in-class miR-124 enhancer with oral administration, how could obefazimod change the treatment landscape for UC, particularly in balancing early-line therapy with options for patients who have cycled through multiple biologics?
Added By: slingshot_insightsAre You Interested In These Questions?
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