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. We expect top-line results from the Phase 3 ABTECT 8-week induction trial in early Q2 2025 and 44-week maintenance data results in Q1 2026.

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.

Active Abivax Pipeline

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

Research

Preclinical

Phase 1

Phase 2

Phase 3

Pivotal Phase 3 program (ABTECT) initiated
First patient enrolled in the US on October 11, 2022

Pivotal Phase 3 program (ABTECT) initiated
First patient enrolled in the US on October 11, 2022 

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

Anticipated Milestones:

  • ABTECT planned induction trial topline data readout in Q3 2025
  • ABTECT planned maintenance trial topline data readout in Q2 2026

Q=quarter.
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3
Obefazimod
 Monotherapy Crohn’s Disease (CD)

Research

Preclinical

Phase 1

Phase 2

Phase 3

Phase 2b trial (ENHANCE-CD) planned

Phase 2b trial (ENHANCE-CD) planned 

Completed & Anticipated Milestones:

  • IND application filed in Q4 2023
  • Initiated patient enrollment of ENHANCE-CD in Q3 2024
  • ENHANCE-CD planned 12-week induction data readout in 2H 2026

2H=second half; IND=Investigational New Drug.
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3
Obefazimod
 Combination Therapy Moderately to Severely Active UC

Research

Preclinical

Phase 1

Phase 2

Phase 3

Anticipated Milestones:

  • Encouraging preclinical combination data generated
  • Decision on combination agent expected in 2025, subject to results of the Phase 3 monotherapy induction trials
Obefazimod Regimen Target Indication Research Preclinical Phase 1 Phase 2 Phase 3
Obefazimod
 Monotherapy Other Inflammatory Indications

Research

Preclinical

Phase 1

Phase 2

Phase 3

Selection of follow-on compound in 2025

Selection of follow-on compound in 2025