Our Pipeline

Entwicklungsprogramme

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 induction results from the Phase 3 ABTECT program in Q1 2025 and top-line maintenance 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 Therapieschema Target Indication Forschung Präklinisch Phase 1 Phase 2 Phase 3
Obefazimod
 Monotherapie Moderately to Severely Active Ulcerative Colitis (UC)

Forschung

Präklinisch

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:

  • Veröffentlichung der Ergebnisse der klinischen Phase-2b-Induktionsstudie
  • 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

Erwartete Meilensteine:

  • ABTECT planned enrollment of last patient into induction trials in Q4 2024
  • Induction trial top-line data readout in Q1 2025
  • Maintenance trial top-line data readout in Q1 2026

Q=quarter.
Obefazimod Therapieschema Target Indication Forschung Präklinisch Phase 1 Phase 2 Phase 3
Obefazimod
 Monotherapie Crohn’s Disease (CD)

Forschung

Präklinisch

Phase 1

Phase 2

Phase 3

Phase-2b-Studie geplant

Phase-2b-Studie geplant

Erreichte & erwartete Meilensteine:

  • 4. Quartal 2023: Zulassung einer klinischen Studie in den USA beantragt (Investigational New Drug application, IND)
  • 3. Quartal 2024: Beginn der Phase-2b-Studie (Behandlung des ersten Patienten)
  • Phase 2b induction top-line results expected in 2H 2026

2H=second half; IND=Investigational New Drug.
Obefazimod Therapieschema Target Indication Forschung Präklinisch Phase 1 Phase 2 Phase 3
Obefazimod
 Kombinationstherapie Moderately to Severely Active UC

Forschung

Präklinisch

Phase 1

Phase 2

Phase 3

Erwartete Meilensteine:

  • 2. Halbjahr 2024: Präklinische Daten als Entscheidungshilfe zur Auswahl der Kombinationstherapie
  • 2025: Entscheidung zum Kombinationswirkstoff erwartet*

*Decision subject to results of the Phase 3 monotherapy induction trials.
Obefazimod Therapieschema Target Indication Forschung Präklinisch Phase 1 Phase 2 Phase 3
Obefazimod
 Monotherapie Andere entzündliche Indikationen

Forschung

Präklinisch

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 

Obefazimod follow-on candidate selection is expected in Q3 2024.