Regulating The
Immune System

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases.

Fighting Inflammatory Diseases

Obefazimod—Abivax's lead drug candidate—is an oral, first-and-only small molecule with a novel mechanism of action that demonstrates enhanced expression of miR-124, which plays a critical role in the regulation of the inflammatory response.

Currently, obefazimod is being tested in phase 3 trials for the treatment of adults with moderately to severely active ulcerative colitis (UC). The initiation of these late-stage trials is building upon the success of the obefazimod phase 2 trials, which demonstrated an onset of symptom relief by day 8 of dosing, with meaningful reductions in rectal bleeding and stool frequency scores.

Abivax is also initiating a phase 2b clinical trial for obefazimod in Crohn's disease (CD) in Q3 2024.

Pipeline

Abivax is continuing to develop obefazimod and evaluate other potential inflammatory indications to pursue, while simultaneously exploring follow-on compounds.

Drug Candidate Regimen Indication Research Nonclinical Phase 1 Phase 2 Phase 3 Completed & Anticipated milestones
Obefazimod
Monotherapy | Moderately to Severely Active
Ulcerative Colitis (UC)
Obefazimod Monotherapy Moderately to Severely Active
Ulcerative Colitis (UC)
Status:
  • Pivotal Phase 3 Program (ABTECT) Initiated
  • First Patient Enrolled in the US on Oct. 11, 2022
Anticipated Milestones:
  • Induction trial topline data readout in Q1 2025
  • Maintenance trial topline data readout in Q1 2026
Monotherapy | Crohn's Disease (CD)
Monotherapy Crohn's Disease (CD)
Status:
  • Phase 2b Trial Planned
Anticipated Milestones:
  • IND filed in Q4 2023
  • Initiate Phase 2b trial in Q3 2024 (first patient in)
  • Phase 2b induction topline results expected in 2H 2026
Combination therapy | Moderately to Severely Active Ulcerative Colitis (UC)
Combination Therapy Moderately to Severely Active
Ulcerative Colitis (UC)
Status:
  • Nonclinical
Anticipated Milestones:
  • Preclinical data to support decision-making on combination agent expected in 2H 2024
  • Decision on combination agent expected in 20251
Monotherapy | Other Inflammatory Indications
Monotherapy Other Inflammatory Indications
Status:
  • Nonclinical
Anticipated Milestones:
  • Declare indication for PoC trial in 2024
1. Decision subject to results of phase 3 monotherapy induction trials

Ulcerative Colitis

Obefazimod is an oral, small-molecule drug candidate in clinical development for the treatment of moderately to severely active UC and has demonstrated anti-inflammatory activity in preclinical studies and in both phase 2a and phase 2b clinical trials.

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Crohn's Disease

Abivax believes obefazimod may result in beneficial effects for patients suffering from CD due to the similar pathophysiology to UC. As a result, Abivax plans on initiating a phase 2b clinical trial to potentially demonstrate outcomes consistent with those observed in the phase 2 clinical trials for UC.

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