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 enrollment of last patient into induction trials in early Q1 2025
  • ABTECT 8-week induction trial top-line data readout in early Q2 2025
  • ABTECT 44-week maintenance trial top-line data readout in Q1 2026
  • Planned NDA submission in late 1H 2026
  • 25 mg long-term extension trial data readout in Q3 2024

1H=first half; NDA=New Drug Application; 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
  • Initiate 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:

  • Preclinical data to support decision-making on combination agent expected in 2H 2024
  • Decision on combination agent expected in 2025*
* Decision 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

Declare indication for a proof-of-concept trial in 2024

Declare indication for a proof-of-concept trial in 2024