Product Development Portfolio

Inflammation

  • Ulcerative Colitis Anti-inflammatory
    Monotherapy
    • Research
    • Preclinical
    • Phase 1
    • Phase 2
    • Phase 3
    Obefazimod Phase 2b completed; First patient in Phase 3 program enrolled in the U.S. in Oct. 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 antiinflammatory 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 2a trial planned in Q1 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.

    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 2a 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.

    Next steps

    Based on the encouraging safety profile and efficacy results observed with obefazimod in UC, Abivax is planning to initiate a Phase 2a clinical trial for the treatment of CD.

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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.

    Next steps

    Evaluation of potential combination therapy opportunities in UC is ongoing, and a decision on a combination agent is expected in 2025, subject to the 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.

    Next steps

    A decision on other potential target indications is expected in 2024.