obefazimod (ABX464) / Abivax - LARVOL DELTA

ABX464-103: Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - P2 | N=355 | Completed | Sponsor: Abivax S.A. | Phase classification: P2b ➔ P2 | N=254 ➔ 355

Enrollment change • Phase classification • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Abivax S.A. | Phase classification: P2a ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis (GlobeNewswire) - "Improvements across all patient reported outcomes (PROs) were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT induction trials evaluating bowel urgency, sleep interruption, fatigue, quality of life, and work productivity for both 50mg and 25mg once-daily obefazimod. At week 8 in the ABTECT 1 & 2 trials, 37% of patients taking once daily 50mg obefazimod reported no bowel urgency (BU) compared to 18.1% of patients in the placebo group (18.9, p"

P3 data • Patient reported outcomes • Ulcerative Colitis

Efficacy and Safety of Obefazimod in Patients With Moderately to Severely Active Ulcerative Colitis: Results From Two, Phase 3, Randomised, Double-Blind, Placebo-Controlled, 8-Week Induction Trials (ABTECT 1 & 2) (Late-Breaking Abstract) (ACG 2025) - P3 | "1272 pts were randomized and treated in ABTECT-1 (636) and ABTECT-2 (636). In both trials, baseline demographics and disease characteristics were similar between groups; 45.3% and 49.3% of pts had inadequate response to ≥ 1 advanced therapy. In both trials, a significantly higher proportion of pts receiving Obe-50 achieved clinical remission and all key secondary endpoints vs."

Clinical • Late-breaking abstract • P3 data • 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

EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES (UEGW 2025) - 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 8 relative to PBO in ABTECT-1, ABTECT-2, and in the pooled analysis. Improvements vs. PBO in clinical response were observed in a pooled analysis in AT-IR-Yes JAKi-IR pts and across lines of therapy up to 4+ AT-IR."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) (UEGW 2025) - P3 | "In both ABTECT induction trials, primary and secondary endpoints were met; obe treatment led to statistically significant improvements in clinical, endoscopic, symptomatic and combined endoscopic-histologic endpoints at week 8. Obe was well tolerated with no new safety signals identified."

Clinical • Late-breaking abstract • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A New Chapter: Phase 3 Induction Results with Obefazimod (UEGW 2025) - "Sponsored By Abivax."

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

OBEFAZIMOD REDUCES TRANSLATIONAL BIOMARKERS OF FIBROSIS IN THE IN VITRO SCAR-IN-A-JAR MODEL [WITHDRAWN] (UEGW 2025) - No abstract available

Preclinical • Fibrosis • Immunology

Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data (GlobeNewswire) - "50 mg once-daily dose of obefazimod led to a pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8; met primary and all key secondary endpoints in both ABTECT 1 and ABTECT 2. ABTECT trials enrolled refractory patient population with 47% of participants having prior inadequate response to advanced therapy, among whom 21% had prior inadequate response to JAK inhibitor therapy....Abivax to present a second late-breaking abstract on October 6."

Late-breaking abstract • P3 data • Ulcerative Colitis

Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting (GlobeNewswire) - "Late Breaking Abstract titled EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) to be presented Sunday, October 5 at 5pm CEST "

Late-breaking abstract • P3 data • Ulcerative Colitis

Abivax Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting (GlobeNewswire) - "Late Breaking Abstract...to be presented Monday, October 6 at 10am CET."

Late-breaking abstract • P3 data • Ulcerative Colitis

ABX464-106: ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 (clinicaltrials.gov) - P3 | N=636 | Completed | Sponsor: Abivax S.A. | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Jul 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

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

Abivax soars 400% after ulcerative colitis drug hits targets in late-stage trials (MSN News) - "Shares of Abivax...surged more than 400% in Paris trading on Wednesday after the French biotech company announced that its experimental drug obefazimod met key goals in two pivotal Phase 3 clinical trials for ulcerative colitis. Topline results from the global ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials showed that a once-daily 50 mg dose of obefazimod achieved statistically significant clinical remission by Week 8, successfully meeting the primary endpoint in both studies....Abivax plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026, pending positive results from an ongoing 44-week maintenance study. Topline results from that trial are expected in the second quarter of 2026."

FDA filing • P3 data: top line • Stock price • Ulcerative Colitis

Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis (GlobeNewswire) - P3 | N=612 | ABTECT-1 (NCT05507203) | P3 | N=612 | ABTECT-2 (NCT05507216) | Sponsor: Abivax S.A. | "Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimens for both trials. Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001) and ABTECT-2 demonstrated 13.4% (p=0.0001), each at the 50 mg once-daily dose, with all key secondary efficacy endpoints being met. The 25 mg once-daily dose of obefazimod achieved the FDA primary endpoint of clinical remission at Week 8 in ABTECT-1 demonstrating a placebo-adjusted remission rate of 21.4%. While the 25 mg dose did not achieve statistical significance for this endpoint in ABTECT-2, it achieved a pooled placebo-adjusted clinical response rate of 28.6%....The ABTECT Maintenance Trial (ABX464-107) is ongoing with top-line results expected to report out in Q2 2026."

P3 data: top line • Ulcerative Colitis

ABX464-105: ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 (clinicaltrials.gov) - P3 | N=639 | Completed | Sponsor: Abivax S.A. | Recruiting ➔ Completed | Trial primary completion date: Mar 2025 ➔ Jun 2025

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

Obefazimod: “Obefazimod achieved statistical significance with both doses in ABTECT 1”; Ulcerative colitis (Abivax) - Investor Call: “Obefazimod met the FDA primary endpoint with 50mg in ABTECT 2”

P3 data: top line • Inflammatory Bowel Disease • Ulcerative Colitis

ABX464-108: Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=203 | Active, not recruiting | Sponsor: Abivax S.A. | Trial completion date: Apr 2027 ➔ Apr 2026 | Trial primary completion date: Feb 2027 ➔ Mar 2026

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

Novel Small-Molecule miR-124 Inducer Acts as "a Physiological Brake" of Inflammation in Ulcerative Colitis by Targeting the PIK3R2/PI3K/Akt Axis. (PubMed, J Med Chem) - "We found that FHND5032 significantly upregulated miR-124 expression in macrophages, surpassing the clinical-stage comparator ABX464 in vitro and in vivo...Safety assessments confirmed no organ toxicity or biochemical abnormalities. Collectively, FHND5032 exerted multifaceted anticolitis effects by targeting the PIK3R2/PI3K/Akt axis, restoring immune homeostasis, and modulating gut microbiota, positioning it as a promising therapeutic agent for UC."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • PIK3R2

Abivax Presents First Quarter 2025 Financial Results (GlobeNewswire) - "Research and development (R&D) expenses increased by EUR 3.6M to EUR -39.3M in the first quarter of 2025 compared to EUR -35.7M in the same period in 2024. This increase was predominantly driven by expenses related to: A EUR 3.0M, or 736% increase related to our Crohn’s Disease (CD) clinical program, driven by the progression of Phase 2b clinical trials for obefazimod in CD..."

Commercial • Crohn's disease

Obefazimod in Patients with Moderate-to-Severely Active Ulcerative Colitis: Efficacy and Safety Analysis from the 96-week Open-label Maintenance Phase 2b study. (PubMed, J Crohns Colitis) - P2 | "The 96-week OLM study supports the long-term efficacy and favorable safety profile of obefazimod 50 mg od. A phase 3 program with obefazimod in patients with moderate-to-severe UC is ongoing."

Journal • P2b data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pain • Ulcerative Colitis

Obefazimod: Patent protection in US related to composition-of-matter until 2029 with extension until 2034 (Abivax) - Corporate Presentation: Patent protection in US related to disease treatment until 2035 with extension until 2039; Patent protection in EU until 2035 and protection of use patent until 2040

Patent • Crohn's disease • 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

Advances in Anthelmintic Target Identification. (PubMed, Int J Mol Sci) - "Advances through the use of whole-organism phenotypic screening have identified some promising nematocidal compounds, including nemacol, tolfenpyrad, UMW-9729, and ABX464...Understanding drug-target interactions in nematodes is critical for developing next-generation anthelmintics and for mitigating the growing resistance challenge. This review outlines recent progress in this area and discusses future directions in target validation and anthelmintic development to support parasite control programmes."

Journal • Review

INTEGRATED SUMMARY OF SAFETY OF OBEFAZIMOD FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (DDW 2025) - P2, P2b | "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 • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pain • Ulcerative Colitis