Pipeline

Product Development Portfolio

Inflammation

  • Ulcerative Colitis Anti-inflammatory
    Monotherapy
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    Obefazimod Pivotal Phase 3 program (ABTECT) initiated; First patient enrolled in the US on October 11, 2022

    Description/Summary:

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

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    Milestones:

    • Phase 2b data from induction study reported
    • Phase 2b data after two years reported from all 217 patients included into the maintenance study
    • Data reported of step-down dosing from 50 to 25 mg for 3rd and 5th year of maintenance treatment
  • Crohn’s Disease Anti-inflammatory
    Monotherapy
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    Obefazimod Phase 2b trial planned

    Description/Summary:

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

    Due to the pathophysiological and clinical similarities of Crohn's disease (CD) and UC, Abivax believes obefazimod has the potential to show beneficial effects in patients suffering from CD and plans to initiate a Phase 2b clinical trial in patients with CD to potentially demonstrate outcomes consistent with those observed in its Phase 2 clinical trials for moderately to severely active UC.

    Completed & Anticipated Milestones:

    • IND filed Q4 2023
    • Initiate Phase 2b trial in Q3 2024 (first patient in)
    • Phase 2b induction topline results expected in 2H 2026

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  • Ulcerative Colitis Combination Therapy
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    Obefazimod Decision on a combination agent expected in 2025

    Description/Summary:

    Obefazimod is an oral, small molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase 2a and Phase 2b clinical trials.
    Based on its early clinical profile, the use of obefazimod as a combination therapy for the treatment of moderately to severely active UC is expected to be explored.

    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.

  • Other inflammatory indications Anti-inflammatory
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    Obefazimod Declare indication for PoC trial in 2024

    Description/Summary:

    Obefazimod is an oral small molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase 2a and Phase 2b clinical trials.
    The anti-inflammatory effect of obefazimod observed during Phase 2 trials to date is encouraging and Abivax is exploring the potential of obefazimod in additional chronic inflammatory conditions.

    Anticipated Milestone:

    • Declare indication for PoC trial in 2024