obefazimod (ABX464) / Abivax - LARVOL DELTA

Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis (GlobeNewswire) - "Abivax SA...announced the completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis....The Phase 3 ABTECT trials (Studies 105 and 106) evaluating obefazimod in patients with moderately to severely active ulcerative colitis successfully enrolled 1,275 participants, exceeding the target enrollment of 1,224 by 4%. Top-line results from the 8-week induction trials anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026. Blinded baseline characteristics align with pre-specified target population and are consistent with Phase 2b UC trial participant characteristics."

Enrollment closed • FDA filing • P3 data: top line • Ulcerative Colitis

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P2 | N=217 | Completed | Sponsor: Abivax S.A. | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P2

Phase classification • Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Abivax Announces Full Year 2024 Financial Results (GlobeNewswire) - "Upcoming Milestones: Completion of Phase 3 ABTECT induction trials enrollment – Q2 2025. Top-line results from induction trials – Q3 2025. Completion of 44-week maintenance trial – Q2 2026. Top-line results from maintenance study – Q2 2026....Research and development (R&D) expenses increased by EUR 43.3M to EUR -146.5M in 2024 compared to EUR -103.2M in 2023. This increase was predominantly driven by increase in expenses related to: Our UC clinical program, driven by the progression of Phase 3 clinical trials for obefazimod in UC."

Commercial • P3 data: top line • Trial completion date • Ulcerative Colitis

INTEGRATED SUMMARY OF SAFETY OF OBEFAZIMOD FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (DDW 2025) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SYNERGISTIC REDUCTION OF INFLAMMATORY CYTOKINES WITH OBEFAZIMOD AND ETRASIMOD IN COMBINATION TREATMENT VS. EITHER MONOTHERAPY IN A MOUSE MODEL OF INFLAMMATORY BOWEL DISEASE (DDW 2025) - No abstract available

Monotherapy • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

IMPACT OF OBEFAZIMOD TREATMENT ON HISTOLOGIC AND COMBINED HISTOLOGIC AND ENDOSCOPIC OUTCOMES IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2B OPEN-LABEL MAINTENANCE STUDY (DDW 2025) - No abstract available

Clinical • P2b data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY AND SAFETY OF OBEFAZIMOD FOR THE FOURTH AND SIXTH YEAR OF OPEN-LABEL MAINTENANCE TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC): 2-YEAR INTERIM ANALYSIS AFTER DOSE DE-ESCALATION TO 25 MG (DDW 2025) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=22 | Completed | Sponsor: Abivax S.A. | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Drug Development in Inflammatory Bowel Diseases: What Is Next? (PubMed, Pharmaceuticals (Basel)) - "This review aims to summarize novel therapeutic target agents in phases II and III of development, including sphingosine-1-phosphate receptor modulators (S1P), anti-interleukin-23 (IL-23), and other small molecules and monoclonal antibodies currently under investigation (e.g., anti-TL1A, obefazimod, NX-13, RIPK-inhibitors)...Anti-IL23p19 therapies, such as risankizumab and mirikizumab, alongside guselkumab, exemplify this class's growing clinical relevance... Ongoing research into long-term safety and the development of personalized treatment strategies remains pivotal to enhance outcomes. Patient stratification and the strategic positioning of these therapies within the expanding treatment landscape are critical for optimizing their clinical impact."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Health related quality of life (HRQOL) in patients with ulcerative colitis (UC) treated with obefazimod: the phase 2 open label maintenance study (ECCO-IBD 2025) - "Table. IBDQ endpoints in the OLE study"

Clinical • HEOR • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of obefazimod treatment on histologic and combined histologic and endoscopic outcomes in patients with moderately to severely active ulcerative colitis: results from the Phase 2b open-label maintenance study (ECCO-IBD 2025) - "Conclusion In this Phase 2b OLM study, patients with moderately to severely active UC treated with obefazimod experienced clinically meaningful improvements in endoscopic, histologic, and combined histologic-endoscopic outcomes with proportions of patients meeting these endpoints consistently increasing from OLM baseline through W96. These data suggest sustained and progressive therapeutic benefits over time."

Clinical • P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Synergistic reduction of inflammatory cytokines with obefazimod and etrasimod in combination treatment vs. either monotherapy in a mouse model of inflammatory bowel disease (ECCO-IBD 2025) - "In the mouse TCT model, the combination of Obe and Etra improved BW and DAI and reduced CD4+ cell numbers and inflammatory cytokines in both colon and blood, showing a synergistic reduction of cytokine levels in the blood. These promising findings suggest that this combination could provide enhanced therapeutic potential for treating inflammatory conditions like UC."

Monotherapy • Preclinical • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IFNG • IL17A • IL6 • TNFA

Efficacy and safety of obefazimod for the fourth and sixth year of open-label maintenance treatment in patients with moderately to severely active ulcerative colitis (UC): 2-year interim analysis after dose de-escalation to 25 mg (ECCO-IBD 2025) - "Conclusion Following 2-4 years of open-label treatment with obefazimod at a dose of 50 mg QD, large percentages of patients maintained efficacy measures on a lower maintenance dose of 25 mg od for two additional years. No new safety signals were observed over up to six years of obefazimod treatment, supporting a favorable long-term risk-benefit profile."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Integrated summary of safety of obefazimod for patients with moderately to severely active ulcerative colitis (ECCO-IBD 2025) - P2, P2a, P2b | "Conclusion This integrated safety analysis of the 4 completed studies in the obefazimod UC clinical program indicates that exposure-adjusted incidence rates of TEAEs were generally numerically lower among patients treated with obefazimod relative to placebo. Integrated safety data further support a favorable safety and tolerability profile."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and safety of dose de-escalation from 50 mg to 25 mg QD of obefazimod maintenance treatment: Analysis of a subset of patients with moderately to severely active ulcerative colitis (UC) who have completed 2 years with 25mg QD (ECCO-IBD 2025) - "Safety was consistent with prior studies, with no new findings. These data further support the long-term efficacy and safety of a lower obefazimod maintenance dose."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

How Does It Work? – Exploring Obefazimod’s Novel Mechanism of Action (ECCO-IBD 2025) - "Sponsored by Abivax"

Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Medical/Product Theatre 2: Learn more about obefazimod—an oral, once daily investigational treatment with a novel mechanism of action in phase 3 clinical trials for ulcerative colitis (ECCO-IBD 2025) - "Sponsored by Abivax"

Clinical • P3 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ENHANCE-CD: Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=212 | Recruiting | Sponsor: Abivax S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • NPPB

Abivax Announces Presentation of Seven Abstracts for Obefazimod in Ulcerative Colitis at 2025 European Crohn’s and Colitis Organization 20th Annual Congress (GlobeNewswire) - "Abivax SA...announced that seven scientific abstracts on its lead drug candidate, obefazimod, [an investigational, orally administered, once-daily small molecule] in clinical development for the treatment of moderately to severely active ulcerative colitis (UC), will be presented at The European Crohn’s and Colitis Organization’s (ECCO’s) 20th Annual Congress as part of scientific exchange, taking place February 19-22, 2025, in Berlin, Germany."

Clinical data • Ulcerative Colitis

Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment (GlobeNewswire) - "Abivax SA...announced a significant milestone in the Phase 3 ABTECT clinical trial evaluating obefazimod for the treatment of moderately to severely active UC....'We are thrilled to announce that the ABTECT Phase 3 trial has reached a significant milestone, with over 1,000 participants enrolled, representing 82% of our targeted enrollment'....ABTECT Phase 3 Update: (i) Enrollment Progress: 1,003 of the targeted 1,224 participants enrolled to date; (ii) Top-Line Results: Induction trial results expected in Q3 2025, with 44-week maintenance data to follow in Q2 2026; (iii) Regulatory Pathway: NDA submission planned for H2 2026, assuming positive clinical data."

Enrollment status • FDA filing • P3 data: top line • Ulcerative Colitis

Corticosteroid-Free Efficacy and Safety of Ulcerative Colitis Patients Receiving Once-Daily Obefazimod in an Open-Label, 96-Week Maintenance Study Among Patients Who Were Receiving Concomitant Corticosteroids at Induction Baseline (AIBD 2024) - "Among patients receiving concomitant CS at induction baseline, meaningful proportions achieved CR, EI, and ER at weeks 48 and 96 in the OLM. Notably, a substantial proportion of patients met CS-free efficacy endpoints despite optional CS tapering. Concomitant CS use at induction baseline had no notable effect on the safety profile of Obe."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of Obefazimod Induction Therapy on Histologic and Combined Histologic and Endoscopic Outcomes in Patients With Moderately to Severely Active Ulcerative Colitis: Week 8 Results from the Phase 2b Induction Trial (AIBD 2024) - "In this Phase 2b induction trial, patients with moderately to severely active UC treated with obefazimod experienced clinically meaningful improvements in histologic and combined histologic and endoscopic outcomes at week 8."

Clinical • P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Obefazimod in Patients With Ulcerative Colitis at Week 48 of an Open-Label Maintenance Study Among Clinical Nonresponses at Week 8 of the Phase 2b Induction Trial (AIBD 2024) - "Substantial proportions of patients treated with obefazimod 50 mg od achieved clinical outcomes at week 48 of an open label maintenance study, irrespective of whether they achieved clinical response at week 8 of the prior induction trial. Patients achieving clinical response at week 8 of the induction trial consistently showed higher efficacy rates throughout the 48-week open-label maintenance trial. The safety profile remains consistent over time, regardless of treatment response at week 8."

Clinical • P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Screening novel antiviral compounds to treat Clostridioides difficile infections. (PubMed, PLoS One) - "difficile activity against a panel of 15 C. difficile isolates, with minimum inhibitory concentrations (MICs) comparable to the drug of choice, vancomycin. These include rottlerin (MIC50 = 0.25 μg/mL), α-mangostin (MIC50 = 1 μg/mL), dryocrassin ABBA (MIC50 = 1 μg/mL), and obefazimod (MIC50 = 4 μg/mL)...All other drugs exhibited bacteriostatic activity. Given their characteristics, these compounds show great promise as novel treatments for CDI."

Journal • Preclinical • Infectious Disease

CORTICOSTEROID-FREE EFFICACY AND SAFETY OF UC PATIENTS RECEIVING ONCE DAILY OBEFAZIMOD IN AN OPEN LABEL, 96-WEEK MAINTENANCE STUDY AMONG PATIENTS WHO WERE RECEIVING CONCOMITANT CORTICOSTEROIDS AT INDUCTION BASELINE (UEGW 2024) - "At entry of the induction trial, pts could receive concomitant CS (prednisone or equivalent [≤20mg/day], budesonide [≤9mg/day], beclomethasone [≤5mg/day]) if on a stable dose ≥2wks immediately before screening; beginning at baseline of the OLM study, CS tapering was recommended but not required. Among pts receiving concomitant CS at induction baseline, meaningful proportions achieved CR, EI, and ER at both wks 48 and 96 in the OLM. Notably, a substantial proportion of pts met CS-free efficacy endpoints despite CS tapering not being required in this OLM study. Concomitant use of CS at induction baseline had no notable effect on the safety profile of Obe."

Clinical • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis