Our Pipeline

Spreading optimism even further

Product Development Portfolio

Abivax is in the process of transforming into a commercial-stage company through opportunities to potentially harness the novel mechanism of action of microRNA-124, with our lead product candidate, obefazimod, and beyond.

Our primary goal is to develop and commercialize obefazimod for the treatment of inflammatory diseases, starting with ulcerative colitis. Top-line results for the 8-week induction trials were announced in Q3 2025, and top-line results for the 44-week maintenance trial were announced in Q2 2026. Patient enrollment for ENHANCE-CD in Crohn’s disease was initiated in Q3 2024; 12-week induction data readout is anticipated mid-year 2027.

Our proprietary chemical library represents further untapped possibilities. We have launched a research effort, based on the mechanistic concept of obefazimod, to discover new potential follow-on drug candidates.

Q=quarter.

Active Abivax Pipeline

Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3 FDA Filing
Obefazimod
 Monotherapy Moderately to Severely Active Ulcerative Colitis (UC)

Research

Preclinical

Phase 1

Phase 2

Phase 3

FDA Filing

First patient enrolled in the US on October 11, 2022
Phase 3 maintenance program (ABTECT) data readout in June 2026

First patient enrolled in the US on October 11, 2022
Phase 3 maintenance program (ABTECT) data readout in June 2026 

Completed Milestones:

  • Phase 2b data from induction study reported
  • Phase 2b data after 2 years reported from all 217 patients included in the maintenance study
  • Data reported of step-down dosing from 50 mg to 25 mg for 3rd and 5th years of maintenance treatment
  • ABTECT induction trials top-line data readout in Q3 2025
  • ABTECT maintenance trial top-line data readout in Q2 2026

Anticipated Milestone:

  • NDA filing expected Q4 2026

NDA=New Drug Application.
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3 FDA Filing
Obefazimod
 Monotherapy Crohn’s Disease (CD)

Research

Preclinical

Phase 1

Phase 2

Phase 3

FDA Filing

Phase 2b trial (ENHANCE-CD) initiated
First patient enrolled on October 3, 2024

Phase 2b trial (ENHANCE-CD) initiated
First patient enrolled on October 3, 2024 

Completed Milestones:

  • IND application filed in Q4 2023
  • Initiated patient enrollment of ENHANCE-CD in Q3 2024

Anticipated Milestone:

  • ENHANCE-CD planned 12-week induction data readout midyear 2027

IND=Investigational New Drug.
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3 FDA Filing
Obefazimod
 Combination Therapy Moderately to Severely Active UC

Research

Preclinical

Phase 1

Phase 2

Phase 3

FDA Filing

Evaluation of obefazimod combined with other agents

Evaluation of obefazimod combined with other agents 

Anticipated Milestones:

  • Encouraging preclinical combination data generated with etrasimod
  • Additional preclinical combination studies are ongoing
  • Decision on combination agent expected in 2026, subject to results of Phase 3 monotherapy induction trials
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3 FDA Filing
Obefazimod
 Monotherapy Other Inflammatory Indications

Research

Preclinical

Phase 1

Phase 2

Phase 3

FDA Filing

Selection of follow-on compound in 2026

Selection of follow-on compound in 2026 

FDA=US Food and Drug Administration.