obefazimod (ABX464) / Abivax - LARVOL DELTA

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

EFFICACY OF OBEFAZIMOD IN PHASE 3 ABTECT-MAINTENANCE TRIAL: RESULTS OF 44-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES (UEGW 2026) - P3 | "Among AT-IR-Yes and AT-IR-No subgroups, improvements in clinical, endoscopic, symptomatic and combined endoscopic-histologic measures were observed in pts treated with Obe at week 44 relative to PBO in the maintenance trial. Improvements vs PBO in clinical remission were observed in AT-IR-Yes JAKi-IR pts and across lines of therapy up to 4+ AT-IR."

Clinical • Metastases • P3 data • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

A FIRST-IN-CLASS GLYCOGEN PHOSPHORYLASE INHIBITOR INV-101: PRECLINICAL EFFICACY IN COLITIS MODELS AND PHASE 1 SAFETY AND PHARMACOKINETICS IN HEALTHY VOLUNTEERS (UEGW 2026) - " In preclinical models, INV-101 significantly improved DAI scores, intestinal barrier integrity and histopathological findings, demonstrating superior efficacy compared to conventional JAK inhibitors and obefazimod in head-to-head studies. INV-101 demonstrated robust anti-inflammatory efficacy and mucosal healing in preclinical IBD models, outperforming current advanced therapies. The equivalent efficacy of the metabolite and its 9-fold higher exposure in humans support its potential as a first-in-class immunometabolism modulator for IBD, warranting advancement into Phase 2 trials in IBD patients, where its favorable safety profile and once-daily dosing may offer advantages over existing therapies."

P1 data • PK/PD data • Preclinical • Gastroenterology • Gastrointestinal Disorder • Hypoglycemia • Immunology • Inflammation • Inflammatory Bowel Disease

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS FROM THE PHASE 2 PROGRAM (UEGW 2026) - "Following 2-4 years of open-label treatment with Obe-50, a high proportion of W144 completer pts have maintained efficacy outcomes through 3 years of treatment with the lower maintenance dose of Obe-25. Maintained and persistent improvements in clinical, endoscopic, and symptomatic measures were observed regardless of prior AT status."

Clinical • Metastases • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 44-WEEK MAINTENANCE TRIAL (ABTECT-MAINTENANCE) (UEGW 2026) - P3 | "Among pts with moderately to severely active UC, both Obe-25 and Obe-50 resulted in higher clinical remission rates than PBO in the maintenance trial, with significant benefits across all key secondary endpoints. Obe was well-tolerated during the 52 weeks of the trial, and no new safety signals were identified."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Pancreatitis • Ulcerative Colitis

OBEFAZIMOD TARGETS MIR-124 TO MODULATE CONSISTANTLY INFLAMMATION AND FIBROSIS ACROSS PRECLINICAL MODELS (UEGW 2026) - "Obe shows consistent anti-inflammatory and anti-fibrotic activity across preclinical models, with in vitro findings confirmed in the TNBS model. The effects observed after establishment of inflammation indicate that its activity is not limited to inflammation control and may extend to modulation of fibroblast-driven tissue remodeling, supported by regulation of TGF-β–associated pathways. Data suggest that TGF-β1 signaling is not suppressed below physiological levels of control mice but rather rebalanced from a disease-associated upregulated state towards control levels."

Preclinical • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • TGFB1

SYMPTOMS OF BOWEL URGENCY AND NOCTURNAL BOWEL MOVEMENTS ARE LINKED WITH IMPROVEMENT IN CLINICAL OUTCOMES AMONG PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS TREATED WITH OBEFAZIMOD: POOLED RESULTS FROM THE 8-WEEK ABTECT PHASE 3 INDUCTION TRIALS (UEGW 2026) - P3 | "In the ABTECT trials, pts who achieved endoscopic and histologic mucosal improvement or remission at Week 8 experienced fewer days of BU and fewer nights of NBM than pts who did not achieve these outcomes. These findings support the positive effect of achieving these endoscopic and histologic mucosal healing outcomes on patient reported QoL."

Clinical • Clinical data • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY, PERSISTENCE, AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: 3-YEAR INTERIM ANALYSIS FOLLOWING DOSE DE-ESCALATION TO 25 MG IN THE OPEN-LABEL MAINTENANCE PHASE 2 STUDY (UEGW 2026) - "After 2-4 years of open-label treatment with Obe-50, a high proportion of pts maintained clinical and symptomatic remission on Obe-25 for up to three additional years. No increased incidence of infections or malignancies and no new safety signals were observed over up to seven years of treatment, supporting a favorable long-term benefit-risk profile and the understanding of the mechanism of action restoring mucosal immune balance without broad immune suppression."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis

OBEFAZIMOD REDUCES INFLAMMATION-DRIVEN TUMOR BURDEN IN A MURINE MODEL OF COLITIS-ASSOCIATED CANCER (UEGW 2026) - "Obe reduces tumor burden in a murine CAC model, with effects that are consistent with previous results showing indirect modulation of inflammation-driven tumorigenesis rather than with direct anti-tumor activity. These findings support a concept whereby Obe exhibits broad anti-inflammatory activity at a central regulatory node, and may limit multiple downstream pathological consequences of chronic inflammation, including anti-fibrotic effects, whether direct or indirect. Confirmation in additional models and further evaluations of translatability to human disease remain required."

Preclinical • Colorectal Cancer • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Solid Tumor • Ulcerative Colitis • CASP3 • CDH1 • CDX2 • CTNNB1 • IL6 • TGFB1 • VIM

Efficacy of Obefazimod Across Baseline Disease Extent and Endoscopic Severity in Ulcerative Colitis: Phase 3 ABTECT Induction Results (ACG 2026) - "Among randomized and treated pts in ABTECT trials, 511 (40%) were graded as MES2 and 761 (60%) MES3; 280 presented with proctosigmoiditis, 474 with left-sided colitis, and 497 with extensive colitis. Baseline demographics and disease characteristics were similar between treatment groups, regardless of baseline MES or disease extent. In the pooled analysis, higher proportions of pts receiving Obe, any dose, vs PBO achieved clinical remission in both the MES2 and MES3 subgroups, and similar trends were observed across all endpoints (Table)."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Obefazimod for Induction Therapy in Moderate-to-Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis (ACG 2026) - "Across 1,556 patients (1,166 obefazimod; 390 placebo), obefazimod significantly improved clinical remission (RR 3.22, 95% CI 1.58â6.54; p=0.001; I²=53.9%), clinical response (RR 1.89, 95% CI 1.62â2.20; p< 0.001; I²=0.0%), endoscopic improvement (RR 3.78, 95% CI 2.50â5.70; p< 0.001; I²=14.4%), and symptomatic remission (RR 1.99, 95% CI 1.47â2.69; p< 0.001; I²=39.4%) versus placebo. No significant increase in serious TEAEs (RR 0.86, 95% CI 0.47â1.57; p=0.62) or TEAEs leading to discontinuation (RR 0.92, 95% CI 0.49â1.71; p=0.79) was observed. Headache (RR 3.70, 95% CI 2.45â5.57; p< 0.001) and nausea (RR 5.15, 95% CI 1.89â14.03; p=0.001) occurred significantly more frequently with obefazimod."

Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Improvements in Bowel Urgency and Nocturnal Bowel Movements Among Patients With Moderately to Severely Active Ulcerative Colitis Treated With Obefazimod: Pooled Results From the Two Phase 3 ABTECT Induction Trials (ACG 2026) - P3 | "A total of 1272 pts were randomized and treated in ABTECT-1 (n=636) and ABTECT-2 (n=636): 1128 pts had BU and 976 pts had NBM data at Baseline. At Week 8, pts treated with Obe reported fewer days of BU vs PBO in both dose groups (p< 0.05). A greater proportion of Obe pts reported no BU: 37.0% for Obe-50 and 37.2% for Obe-25 vs 18.1% for PBO (Obe-50: D19.2, Obe-25: D18.9, p< 0.05), with BU remission observed as early as Week 3."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Favorable Safety Profile of Obefazimod With No Increased Risk of Infection: Integrated Analysis of Phase 3 Induction Trials in Ulcerative Colitis (ACG 2026) - P3 | "1272 pts were randomized and treated in ABTECT induction trials, 636 pts received Obe-50, 319 received Obe-25, and 317 received PBO. Baseline demographics and disease characteristics were comparable across treatment groups with median exposures of 60-61 days (Table 1). Proportions of pts who reported at least one TEAE were 60.2%, 48.9%, and 50.8% for Obe-50, Obe-25, and PBO, respectively."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immune Modulation • Immunology • Infectious Disease • Inflammatory Bowel Disease • Pancreatitis • Prostate Cancer • Solid Tumor • Ulcerative Colitis

Rapid and Progressive Improvement With Obefazimod in Ulcerative Colitis in the ABTECT Induction Program: Subgroup Analysis by Prior Advanced Therapy Failure Status and Therapeutic Class (ACG 2026) - "Abstract text will be released on Sunday, October 11, 2026, at 12:00 pm CT (1:00 pm ET) when the ACG 2026 embargo lifts."

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

miR-124 upregulation as a new therapeutic strategy: The evolving role of obefazimod in ulcerative colitis. (PubMed, Curr Opin Pharmacol) - "Obefazimod represents a promising addition to the therapeutic landscape for moderate-to-severe UC. Key questions remain regarding its optimal positioning, real-world effectiveness, and potential role in rational combination regimens to further improve remission depth and durability."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL2

Anticipated Upcoming Key Dates (GlobeNewswire) - "(i) End of 2026 - Planned NDA submission for obefazimod in UC; (ii) Mid-2027 - Topline results from the Phase 2b ENHANCE-CD induction trial evaluating obefazimod in CD."

FDA filing • P2b data • Crohn's disease • Ulcerative Colitis

Abivax…announced the successful completion of its positive pre-New Drug Application (NDA) interaction with the U.S. Food and Drug Administration (FDA) for obefazimod for the treatment of adults with moderately to severely active ulcerative colitis (UC) (GlobeNewswire) - "Constructive FDA feedback resulted in alignment on the Company's planned NDA submission strategy and supported the planned content and format of the NDA submission. Abivax remains on track to submit its first NDA for obefazimod by the end of 2026....'This progress builds on the positive Phase 3 ABTECT program results'..."

FDA event • FDA filing • Ulcerative Colitis

A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis (ChiCTR) - P3 | N=1050 | Completed | Sponsor: The First Affiliated Hospital,Sun Yat-sen University; The First Affiliated Hospital,Sun Yat-sen University

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABX464-107: ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: Abivax S.A. | Trial primary completion date: Dec 2029 ➔ Jan 2026

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1050 | Not yet recruiting | Sponsor: Abivax S.A.

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: Abivax S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABX464-107: ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: Abivax S.A. | Trial completion date: Jun 2026 ➔ Jan 2030 | Trial primary completion date: Jan 2026 ➔ Dec 2029

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1050 | Recruiting | Sponsor: Abivax S.A. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Apr 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ABTECT - Maintenance (clinicaltrials.gov) - P3 | N=1116 | Active, not recruiting | Sponsor: Abivax S.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2030 ➔ May 2030 | Trial primary completion date: Jan 2026 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database (GlobeNewswire) - "Obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis ('UC') population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment. Dose escalation to obefazimod 50 mg recaptured clinical remission in 45.5% of patients who relapsed during ABTECT Maintenance Part 1, supporting a practical dose-escalation strategy for regaining and sustaining disease control over time....In ABTECT Maintenance Part 2, EAIRs for malignancies excluding NMSC were 0.48 and 0.69 events per 100 PYs, and for NMSC were 0.95 and 0.69 events per 100 PYs, in the all-active combined and 50 mg cohorts respectively, all consistent with expected UC background rates."

P3 data: top line • Ulcerative Colitis