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ABIVAX (ABVX) Earnings Call Presentation
2025-07-22 20:30
ABTECT Phase 3 Program Overview - The ABTECT Phase 3 program included 2 induction trials (ABX464-105, ABX464-106) and 1 maintenance trial (ABX464-107) [25] - The trials enrolled 1,275 patients across 36 countries [20, 60] - The trials included both advanced therapy naïve (52.7%) and refractory patients (47.3%) [60] Efficacy Results - In ABTECT 1 (Study 105), the 50mg dose of obefazimod achieved a clinical remission rate of 21.7%, a 19.3% difference compared to placebo (2.5%) (p<0.0001) [33, 60] - In ABTECT 2 (Study 106), the 50mg dose of obefazimod achieved a clinical remission rate of 19.8%, a 13.4% difference compared to placebo (6.3%) (p=0.0001) [40, 60] - Pooled analysis of ABTECT 1 & 2 showed a clinical remission rate of 20.8% with 50mg obefazimod, a 16.4% difference compared to placebo (4.4%) (p<0.0001) [47, 60] - In ABTECT 1, the 25mg dose of obefazimod achieved statistically significant results on all key secondary endpoints [36] - In ABTECT 2, the 50mg dose of obefazimod achieved statistical significance on all key secondary endpoints [43] Safety and Tolerability - Obefazimod was generally well tolerated with no new safety signals observed in Phase 3 induction trials [20, 60] - In ABTECT 1, Any TEAE was 46.9% for Obe 25 mg, 59.4% for Obe 50 mg, and 53.2% for Placebo [52] - In ABTECT 2, Any TEAE was 50.9% for Obe 25 mg, 61.0% for Obe 50 mg, and 48.4% for Placebo [52] Next Steps - 44-week maintenance data is expected in Q2 2026 [25, 60]