EQS-News

Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months - Seite 2

Didier Blondel, Chief Financial Officer of Abivax, adds: “With the successful Nasdaq IPO in October 2023, the largest ever Nasdaq IPO of a French-listed biotech company, we expect to be fully financed through the planned data read-outs of the UC and CD induction trials. In parallel, we continue to implement our multi-pronged financing strategy to fund our ambitious projects in 2024 and beyond, with the objective to increase shareholder value.”

Clinical trial priorities and milestones

Obefazimod Phase 3 program in UC (ABTECT)

The obefazimod Phase 3 ABTECT program investigating efficacy and safety in adults with moderately to severely active UC is progressing. Recruitment into both induction trials, ABTECT-1 and ABTECT-2, is ongoing in all designated regions.

The ABTECT program is designed for 1,200 UC patients across 36 countries in over 600 trial sites to take part in the pivotal Phase 3 program that covers North America, Europe, Latin America and Asia Pacific. Clinical remission is the primary endpoint for the eight-week induction trials as well as for the maintenance trial at week 52 (which is week 44 of the maintenance trial).

Anticipated milestones:

• Q4 2024: ABTECT planned enrollment of last patient into induction trials
• Q1 2025: ABTECT planned top-line induction data read-out after eight weeks of treatment
• Q1 2026: ABTECT planned top-line maintenance results after one year of treatment

Objectives:

• Obtain robust Phase 3 data for obefazimod in moderately to severely active UC as a potentially differentiated oral treatment option
• Establish obefazimod as a potential first-line advanced therapy for the treatment of UC

Obefazimod 25 mg long-term extension trial in UC

UC patients initially treated with 50 mg of oral, once-daily obefazimod and who completed the Phase 2a or Phase 2b maintenance trials could roll over into a follow-on, open-label maintenance trial with a reduced dose of 25 mg.

In an interim analysis as of July 31, 2023, of the 71 eligible patients, 63 completed their 48-week visit, with a demonstrated disease control rate (stable or improved Modified Mayo Score) of 84% (53 of 63 patients) with the 25 mg once-daily dose of obefazimod. No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.