Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
Rhea-AI Summary
Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, enrolling 1,003 out of 1,224 targeted participants (82%) for treating moderately to severely active ulcerative colitis. The company expects to complete enrollment in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025.
The 44-week maintenance data is expected in Q2 2026, followed by NDA submission in H2 2026 if successful. The blinded baseline characteristics align with the pre-specified target population and are consistent with the Phase 2b UC trial. The company confirms its cash runway extends through the ABTECT induction trial readout and into Q4 2025, with no additional financing needed.
The trial's safety profile shows no new safety signals under the oversight of the independent Data Monitoring Committee. Obefazimod is being developed as a potentially first-in-class oral treatment option for UC patients.
Positive
- 82% enrollment completion (1,003 of 1,224 participants) in Phase 3 ABTECT trial
- Sufficient cash runway through Q4 2025 with no additional financing needed
- No new safety signals observed in the trial
- Baseline characteristics align with Phase 2b trial expectations
Negative
- Enrollment completion delayed to Q2 2025 due to UC trial recruitment competition
- Top-line results timeline pushed to Q3 2025
Insights
The Phase 3 ABTECT trial's 82% enrollment completion with 1,003 participants represents a important advancement in obefazimod's development pathway. The trial's rapid enrollment pace, despite intense competition in UC trials, suggests strong investigator confidence and patient interest. The balanced recruitment strategy between bio-naïve and bio-experienced patients enhances the study's potential real-world applicability.
The trial design demonstrates robust scientific methodology, with the 8-week induction period followed by a 44-week maintenance phase allowing comprehensive efficacy assessment. The alignment of blinded baseline characteristics with Phase 2b data strengthens internal validity and increases confidence in potential outcome reproducibility. The absence of new safety signals under DMC oversight is particularly encouraging for this novel oral therapeutic approach.
This milestone carries significant market implications. The confirmed cash runway extending through Q4 2025 provides important operational flexibility and de-risks the path to top-line data readout. The strategic timing of anticipated NDA submission in H2 2026 positions ABVX to potentially capture share in the
The trial's progression timeline, particularly the Q3 2025 readout, creates a clear catalyst pathway for potential value creation. The company's market cap of
Obefazimod's development as a first-in-class oral treatment for UC represents a potential paradigm shift in treatment options. The current standard of care often relies on biologics, creating a substantial market opportunity for an effective oral alternative. The large trial size of 1,224 participants provides robust statistical power to demonstrate efficacy.
The dual-phase trial design (8-week induction + 44-week maintenance) aligns with regulatory requirements and enables comprehensive safety and efficacy evaluation. The balanced recruitment strategy between treatment-naïve and experienced patients will provide valuable insights into obefazimod's potential positioning in the treatment algorithm. The maintained safety profile at this advanced stage of development is particularly encouraging for chronic inflammatory disease therapeutics.
Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment
- Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis (“UC”) reaches 1,003 of 1,224 participants, representing
82% of target enrollment. Enrollment completion expected in Q2 2025. - Top-line results for the 8-week induction trial anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026.
- Blinded baseline characteristics align with pre-specified target population and consistent with Phase 2b UC trial
- Cash runway through ABTECT induction trial readout and into Q4 2025
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
Mr. de Garidel went on to say, “In order to ensure a balanced representation of bio-naïve 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.
Didier 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
- Enrollment Progress: 1,003 of the targeted 1,224 participants enrolled to date.
- Top-Line Results: Induction trial results expected in Q3 2025, with 44-week maintenance data to follow in Q2 2026.
- Regulatory Pathway: NDA submission planned for H2 2026, assuming positive clinical data.
- Participant Characteristics: Blinded baseline data aligns with the target population defined during Phase 2b.
- Safety Profile: No new safety signals observed to date with the oversight of the independent Data Monitoring Committee.
About Abivax
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 ulcerative colitis.
Contact
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for 2025 and 2026, including anticipated timing for top-line data readout of its ABTECT clinical trials and NDA submission, potential therapeutic benefit of obefazimod, and the Company’s expected cash runway. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
FAQ
What is the current enrollment status of Abivax's Phase 3 ABTECT trial for obefazimod?
When will Abivax (ABVX) release top-line results for the ABTECT Phase 3 trial?
What is the cash runway status for Abivax's ABTECT trial?
When does Abivax plan to submit the NDA for obefazimod?
What is the safety profile of obefazimod in the ABTECT Phase 3 trial?
