EQS-News

Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months - Seite 3

Anticipated milestones:

• Q3 2024: New obefazimod UC extension trial read-out after one and two years of continued treatment with reduced dose of 25 mg

Objectives:

• Confirm safety and efficacy data of Phase 2 maintenance trials and long-term extension trial interim analysis
• Confirm safety and efficacy results for reduced dose of 25 mg obefazimod for chronic long-term use
• Conduct further clinical laboratory parameter analysis to validate obefazimod’s novel mechanism of action and its capacity to relieve UC symptoms

Obefazimod Phase 2 trial in Crohn’s disease (ENHANCE-CD)

Based on existing supportive preclinical and clinical Inflammatory Bowel Disease (IBD) data, Abivax is advancing obefazimod in a Phase 2 trial in moderately to severely active Crohn’s disease (CD).

Anticipated milestones:

• Q4 2023: IND for ENHANCE-CD trial was submitted and cleared. Abivax is currently evaluating FDA comments and will consider any recommended adjustments to trial design
• H2 2025: ENHANCE-CD planned top-line induction data read-out pending decision to modify the trial design after evaluation of FDA comments

Objectives:

• Reproduce obefazimod UC Phase 2 safety and efficacy data for the treatment of CD

R&D progress

• Obefazimod in combination therapy: Based on its early clinical profile, the formal process evaluating combination therapy of oral and injectable candidates with obefazimod in UC is ongoing and preclinical data to support decision-making on a combination agent is expected in 2H 2024.
• Obefazimod follow-on candidate selection from miR-124 library: R&D work on potential follow-on drug candidates to be selected from Abivax’s compound library is ongoing. Selection of the first follow-on drug candidate is expected in Q3 2024 to further strengthen the Abivax pipeline.

Anticipated Milestones: