Full Press Release Details
Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
PARIS, France January 9, 2025 5:35 PM CET Abivax SA (Euronext Paris: FR0012333284 ABVX / Nasdaq: ABVX)
( Abivax or the Company ), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced a significant milestone in the Phase 3 ABTECT clinical trial evaluating
obefazimod for the treatment of moderately to severely active UC.
Marc de Garidel, Chief Executive Officer of Abivax, commented:
We are thrilled to announce that the ABTECT Phase 3 trial has reached a significant milestone, with over 1,000 participants enrolled, representing 82%
of our targeted enrollment. This progress underscores the enthusiasm of investigators and patients for this important trial, which remains among the fastest-enrolling Phase 3 UC trials to date.
Mr. de Garidel went on to say, In order to ensure a balanced representation of bio-na ve and bio-experienced participants amid heightened competition in UC trial recruitment, we now anticipate completing enrollment in Q2 2025 and delivering top-line results for the 8-week induction trial in Q3 2025. With the ABTECT trial, we aim to validate the value of obefazimod as a potentially first-in-class safe and effective oral treatment option,
which remains a significant unmet need for patients with UC.
Looking Ahead to 2025:
With Phase 3 enrollment nearing completion and key data readouts on the horizon, the Company believes 2025 is shaping up to be a pivotal year. Beyond the
ABTECT trial, the Company is advancing its broader portfolio to address chronic inflammatory conditions that affect millions worldwide.
Blondel, Chief Financial Officer of Abivax, added:
Without the need for additional financing, our cash runway extends beyond the expected top-line results from the ABTECT induction trial and into Q4 2025, ensuring we remain well-positioned to execute our strategy.
ABTECT Phase 3 Update:
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body s natural regulatory mechanisms to stabilize the
immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active
SVP, Investor Relations
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