Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

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Abivax (NASDAQ:ABVX) announced the acceptance of a second late-breaking abstract for its lead drug candidate obefazimod at the 2025 United European Gastroenterology (UEG) Meeting. The presentations will showcase results from the ABTECT Phase 3 induction trials for treating moderately to severely active ulcerative colitis.

Two key presentations are scheduled: The first by Dr. Bruce Sands on October 5, focusing on efficacy and safety results from the 8-week induction trials (ABTECT-1 & 2), and the second by Dr. Silvio Danese on October 6, examining efficacy in patient subsets with and without prior inadequate response to advanced therapies. According to Chief Medical Officer Dr. Fabio Cataldi, the trials demonstrated statistically significant and clinically meaningful activity with an impressive safety profile.

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Biotech Clinical Development Expert

Abivax's Phase 3 trial results for obefazimod in ulcerative colitis to be presented at major medical conference, showing positive efficacy and safety.

The acceptance of two late-breaking abstracts for presentation at the United European Gastroenterology Congress represents significant validation for Abivax's lead candidate obefazimod. Late-breaking slots at major medical conferences are highly competitive and typically reserved for the most impactful clinical findings.

The presentations will focus on the ABTECT Phase 3 induction trials testing obefazimod in moderately to severely active ulcerative colitis patients. According to the press release, these trials demonstrated statistically significant and clinically meaningful activity with an impressive safety and tolerability profile during the 8-week induction period.

Particularly notable is the second presentation examining efficacy in patient subgroups with and without prior inadequate response to advanced therapies. This analysis addresses a critical unmet need, as treatment-refractory patients represent a challenging population with limited options.

Obefazimod is positioned as a potential first-in-class oral treatment for ulcerative colitis. If approved, it would enter a substantial market currently dominated by injectable biologics and JAK inhibitors. An oral therapy with strong efficacy and safety could significantly disrupt the treatment paradigm for inflammatory bowel diseases.

The presentations by key opinion leaders Dr. Bruce Sands and Dr. Silvio Danese further validate the credibility of Abivax's clinical program. These high-profile sessions will provide crucial visibility to gastroenterologists and potential pharmaceutical partners, potentially setting the stage for regulatory submissions if the data supports efficacy claims.

Abivax Announces Acceptance of Additional
Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

• Late Breaking Abstract titled EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) to be presented Sunday, October 5 at 5pm CEST 
  
  

PARIS, France – September 29, 2025 – 10:05 PM CEST – 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 the presentation of a second late breaking abstract for its lead drug candidate, obefazimod, for the treatment of moderately to severely active ulcerative colitis (UC) at The United European Gastroenterology Congress, taking place October 4-7, 2025, in Berlin, Germany.

"The acceptance of this additional late-breaking abstract underscores the significance of the ABTECT Phase 3 induction trial results which demonstrate the statistically significant and clinically meaningful clinical activity and impressive safety and tolerability profile of obefazimod in patients with moderately to severely active ulcerative colitis during the 8-week induction trials. These findings are crucial steps towards potentially offering a novel, first-in-class oral treatment option for patients who urgently need new therapeutic approaches to achieve and maintain remission," said Fabio Cataldi, MD, Chief Medical Officer of Abivax.

Obefazimod data to be presented:

Presentation Title	Session	Presenter	Presentation/ Session Number	Session Hall	Date and Time (CEST)
EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2)	Late-breaking trials in IBD	Bruce Sands, MD	LB /01	Room Helsinki	Sunday, October 5, 2025 5:00 to 5:12pm CEST
EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES	Hot off the press: IBD Treatment	Silvio Danese, MD	LB / 06	Room Helsinki	Monday, October 6, 2025 10:00am to 10:12am CEST

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. 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 the potential therapeutic benefit of obefazimod, and the Company’s participation at industry conferences. 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 March 24, 2025 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 will Abivax (ABVX) present at the 2025 UEG Meeting?

Abivax will present two late-breaking abstracts on obefazimod, showcasing results from ABTECT Phase 3 induction trials for ulcerative colitis treatment, including efficacy, safety, and analysis of patient subsets.

When and where will the ABTECT Phase 3 trial results be presented?

The results will be presented at the UEG Congress in Berlin on October 5, 2025, at 5:00 PM CEST by Dr. Bruce Sands, with a second presentation on October 6, 2025, at 10:00 AM CEST by Dr. Silvio Danese.

What are the key findings from Abivax's obefazimod trials for ulcerative colitis?

According to the CMO, the trials showed statistically significant and clinically meaningful activity with an impressive safety and tolerability profile in patients with moderately to severely active ulcerative colitis during the 8-week induction trials.

Who will be presenting the Abivax ABTECT trial data at UEG 2025?

Dr. Bruce Sands will present the primary efficacy and safety results, while Dr. Silvio Danese will present data on patient subsets with and without prior inadequate response to advanced therapies.