Abivax Hits Milestone in Phase 3 Trials for Ulcerative Colitis
Abivax Completes Enrollment in Phase 3 ABTECT Trials
Abivax, a clinical-stage biotechnology company focused on chronic inflammatory diseases, has successfully completed the enrollment for its Phase 3 ABTECT trials. These studies are exploring the use of obefazimod, a promising therapeutic candidate for patients suffering from moderately to severely active ulcerative colitis. Impressively, the trials managed to enroll 1,275 participants, which surpasses the initial target of 1,224 by 4%.
Overview of the ABTECT Trials
The Phase 3 ABTECT trials, encompassing Studies 105 and 106, aim to assess the efficacy of obefazimod in treating ulcerative colitis, a condition that significantly impacts patients' quality of life. Top-line results from these 8-week induction trials are anticipated by the third quarter of 2025, while long-term maintenance data is expected to follow in the second quarter of 2026. Should the trials showcase positive results, Abivax is planning to file a New Drug Application (NDA) in the latter half of 2026.
Key Milestones Achieved
Marc de Garidel, CEO of Abivax, noted that completing the enrollment phase is a major achievement for both the company and the ulcerative colitis patient community. He expressed confidence in the potential of obefazimod to meet the significant unmet medical needs in this area.
Participant Demographics and Characteristics
The enrolled participants exhibited baseline characteristics that align with the targeted patient population. Those aspects were consistent with the data gathered from the previous Phase 2b clinical trial. Data from this previous trial will provide a solid basis for comparison as the company delves into this pivotal stage of development.
Financial and Operational Outlook
Abivax's financial strategy ensures a solid cash runway through the induction trials and into early 2026. This liquidity is essential for navigating the complexities of clinical trials and the subsequent phases of regulatory review. With positive outcomes anticipated, Abivax is strategically positioned to advance its groundbreaking work in this therapeutic domain.
Safety and Monitoring Practices
As part of their rigorous safety monitoring, a recent review by the Data Safety Monitoring Board (DSMB) showed no new safety signals. This reinforces the ongoing confidence in the clinical program’s integrity and the commitment to participant safety throughout the trials.
Patient Insights and Community Support
Patient engagement and feedback are critical components of the trial process. The company remains dedicated to communicating transparently with the community as results progress. As such, Abivax will continue to provide updates and insights into how the trials are aligning with patient needs and expectations.
About Abivax
Abivax is a cutting-edge biotechnology firm dedicated to developing novel therapeutics leveraging the body's regulatory mechanisms to stabilize immune responses in chronic inflammatory conditions. With a footprint in both France and the United States, Abivax continues to carve out a niche within the biotech landscape, especially with their leading candidate, obefazimod, currently in Phase 3 clinical trials.
Contact Information
For further inquiries, please contact:
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878
Frequently Asked Questions
What are the ABTECT trials about?
The ABTECT trials aim to evaluate the efficacy of obefazimod in patients with moderately to severely active ulcerative colitis.
How many participants were enrolled in the ABTECT trials?
A total of 1,275 participants were successfully enrolled.
When are the anticipated results for the trials?
The top-line results from the induction trials are expected in the third quarter of 2025, with maintenance data following in the second quarter of 2026.
What is the aim of obefazimod?
Obefazimod is being researched to provide a new therapeutic option for patients suffering from ulcerative colitis, addressing unmet medical needs.
Who can I contact for more information?
You can reach out to Patrick Malloy, SVP of Investor Relations, at patrick.malloy@abivax.com.
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