Abivax Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting

Rhea-AI Summary

Abivax (NASDAQ: ABVX) announced the upcoming presentation of a late-breaking abstract for obefazimod, their lead drug candidate for treating moderately to severely active ulcerative colitis (UC), at the 2025 United European Gastroenterology (UEG) Meeting in Berlin. The presentation, titled "Efficacy of Obefazimod in ABTECT Phase 3 Induction Trials," will take place on October 6, 2025, at 10:00 AM CET.

The company will host an analyst and investor call at 3 PM CET on the same day and conduct a symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" at 5:30 PM CET. The presentation will focus on 8-week therapy results in patients with and without prior inadequate response to advanced therapies.

Insights

Clinical Research Expert

Abivax's upcoming Phase 3 data presentation for obefazimod at UEG represents a crucial milestone in their ulcerative colitis program.

This announcement signals a significant milestone in Abivax's clinical development program for obefazimod in ulcerative colitis (UC). The acceptance of a late-breaking abstract at the prestigious United European Gastroenterology (UEG) Meeting indicates the scientific community recognizes the potential importance of these Phase 3 results. The abstract title specifically mentions efficacy results in patient subgroups with and without prior inadequate response to advanced therapies - a crucial differentiation point in today's competitive inflammatory bowel disease market.

The ABTECT Phase 3 induction trials represent the pivotal studies that will determine whether obefazimod advances toward regulatory approval. The 8-week efficacy data being presented will likely include the primary endpoint results that regulatory agencies will scrutinize. Importantly, the company is highlighting results in patients who previously failed advanced therapies, suggesting potential efficacy in treatment-resistant populations - a significant unmet need in UC management.

The company's decision to hold both an investor call and a scientific symposium immediately following the data presentation suggests management has confidence in the results. The symposium title "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" positions obefazimod as potentially transformative rather than merely incremental in the treatment landscape, likely reflecting its novel mechanism of action compared to existing therapies.

This presentation represents a pivotal moment for Abivax, as Phase 3 data typically forms the backbone of regulatory submissions and determines commercial viability of drug candidates in late-stage development.

Abivax Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting

• Late Breaking Abstract titled 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 to be presented Monday, October 6 at 10am CET
  
  
• Abivax management to hold an analyst and investor call on October 6 at 3pm CET / 9am ET to discuss data
  
  
• Abivax to hold symposium titled “From Evolution to Revolution: New Mechanisms in Ulcerative Colitis” on October 6 from 5:30 – 6:30pm CET
  
  

PARIS, France – September 23, 2025 – 10:05 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 the presentation of a 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 the late-breaking abstract for presentation at UEG underscores the potential of obefazimod as a new therapeutic option for patients with ulcerative colitis,” said Fabio Cataldi, MD, Chief Medical Officer of Abivax. “We are eager to share the detailed findings from our ABTECT Phase 3 induction trials, which we believe will demonstrate the efficacy of obefazimod in a diverse patient population, including those who have not responded adequately to other advanced therapies.”  

Additional UEG and Abivax Events

• Analyst and Investor Call: Abivax management will host a call to discuss the data on Monday, October 6 at 3 PM CET / 9 AM ET. https://edge.media-server.com/mmc/p/tjj8438w
  
  
• Abivax Symposium: A symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" will be held on the evening of Monday, October 6, from 5:30 PM – 6:30 PM CET in Room Helsinki. This event will provide an in-depth look at new therapeutic approaches for UC including a presentation of the ABTECT Phase 3 induction data.
  
  
• Abivax Booth: For more information and to speak with Abivax representatives, visit the Abivax booth at the UEG exhibitor hall (Booth #4.25 in Hall 4.2).
  
  

Further details about the congress can be found on the UEG website.

Obefazimod data to be presented:

Presentation Title	Session	Presenter	Presentation/ Session Number	Session Hall	Date and Time (CET)
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	LB / 06	Room Helsinki	Monday, October 6, 2025 10:00am to 10:12am

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

When will Abivax (ABVX) present the Phase 3 ABTECT trial results for obefazimod at UEG 2025?

Abivax will present the results on Monday, October 6, 2025, at 10:00 AM CET in Room Helsinki during the 'Hot off the press: IBD Treatment' session.

What is the purpose of Abivax's obefazimod clinical trials in ulcerative colitis?

The ABTECT Phase 3 trials evaluate obefazimod's efficacy in treating moderately to severely active ulcerative colitis, including patients with and without prior inadequate response to advanced therapies.

When is the Abivax (ABVX) investor call to discuss the ABTECT Phase 3 data?

Abivax will host an analyst and investor call on October 6, 2025, at 3:00 PM CET / 9:00 AM ET to discuss the trial data.

What additional events is Abivax hosting at UEG 2025?

Abivax will hold a symposium titled 'From Evolution to Revolution: New Mechanisms in Ulcerative Colitis' on October 6 from 5:30-6:30 PM CET and will have a booth (#4.25) in Hall 4.2.

Who will present the Abivax ABTECT Phase 3 trial results at UEG 2025?

Silvio Danese will present the late-breaking abstract (LB/06) during the 'Hot off the press: IBD Treatment' session.