Tue, 12 Dec 2023

  • Abivax abstract on obefazimod phase 2b results selected for moderated poster presentation at UEG Week 2022
  • Obefazimod (ABX464) interim 48-week safety and efficacy analysis from the ongoing phase 2b maintenance study in moderate-to-severe ulcerative colitis (UC) selected by UEG as 'one of the best abstracts' and eligible for an oral presentation at a moderated poster session
  • Principal investigator Prof. Séverine Vermeire, M.D., Ph.D., to present Abivax's poster on October 10, 2022, at 11:54 a.m.- 12:00 (noon) CEST (5:54 a.m.-6:00 a.m. EST)

PARIS, FRANCE / ACCESSWIRE / September 27, 2022 / Abivax SA (Euronext Paris:FR0012333284 - ABVX), a phase 3 clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces today that its abstract on the obefazimod interim 48-week safety and efficacy analysis from the ongoing open-label phase 2b maintenance study in moderate to severe ulcerative colitis (UC) has been selected as 'one of the best abstracts' for UEG (United European Gastroenterology) Week 2022. The corresponding poster is therefore eligible for an oral presentation during a moderated poster session, in addition to the poster exhibition in the Science Lounge and the Virtual Poster Exhibition.

UEG Week 2022 takes place in Vienna, Austria, from October 8-11, 2022, and is one of the world's leading congresses focused on gastrointestinal diseases, such as Inflammatory Bowel Diseases (IBD).

The poster will be presented by Prof. Séverine Vermeire, M.D., Ph.D., the study's principal investigator. Participants will have the opportunity to ask questions after the presentation.




Clinical trials in IBD - Moderated Poster Session 3 (MP250)


ABX464 (obefazimod) in patients with moderate-to-severe ulcerative colitis: An interim 48-week safety and efficacy analysis from an ongoing 96-week open-label maintenance phase 2b study


October 10, 2022 - at 11:54 a.m.-12:00 (noon) CEST (5:54-6:00 a.m. EST)


Prof. Séverine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium, and principal investigator of the obefazimod phase 2a and phase 2b clinical studies, as well as of the obefazimod global phase 3 clinical program in UC

The moderated poster sessions at this year's UEG Week will neither be recorded nor streamed online. Only registered UEG Week participants can attend the poster session at the conference venue.

In addition to the selection of the abstract by UEG, the obefazimod phase 2b study results in UC have recently been scientifically validated with the publication of an article in the peer-reviewed journal 'The Lancet Gastroenterology & Hepatology'.[1] The title of the article is 'ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension'.[2]

Obefazimod global pivotal phase 3 clinical program in UC

Following the promising results of the phase 2a and phase 2b clinical induction and maintenance studies with obefazimod in UC, Abivax launched a global pivotal phase 3 clinical program with its drug candidate in moderate to severe ulcerative colitis patients.

1,200 UC patients across 36 countries will take part in the pivotal phase 3 program that consists of two induction studies and a single subsequent maintenance study (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) induction trials and ABTECT maintenance trial (ABX464-107)). These three pivotal studies are all randomized, double-blind, and placebo controlled, using independent, blinded review of the videotaped endoscopies. The primary efficacy endpoint assessed at week 8 (induction) and at week 44 (maintenance) will be clinical remission according to the modified Mayo Score, as required by FDA.[3]

Currently, more than 430 study sites, out of the targeted 600 sites, have already been qualified to take part in the phase 3 trials.

In August, Abivax received approval from the central US Institutional Review Board (IRB) for the protocols of the phase 3 induction studies. This allows the initiation of enrollment of patients into the two studies in UC in the US. A first patient is anticipated to be included at the end of September 2022.


About Abivax (www.abivax.com)

Abivax, a phase 3 clinical stage biotechnology company, is developing novel therapies that modulate the body's natural immune machinery to treat patients with chronic inflammatory diseases, viral infections, and cancer. Abivax, founded by Truffle Capital, is listed on Euronext compartment B (ISIN: FR0012333284 - Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, obefazimod (ABX464) to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma. More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.


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This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company's programs. Although Abivax' 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 registration document (Document d'Enregistrement Universel). 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, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. 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 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) which 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 securities of the Company in any jurisdiction, in particular in France. 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 judgement. 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.

[1] 'The Lancet Gastroenterology & Hepatology' has an Impact Factor of 45 (2021 Journal Citation Reports ®, Clarivate 2022).

[2] Severine Vermeire et al.: ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48-week, open-label extension, Lancet Gastroenterol Hepatol, published online on Sept. 5, 2022.

[3] Modified Mayo Score refers to stool frequency, rectal bleeding and endoscopy sub score.


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