EQS-News: Abivax receives FDA agreement on pediatric development plan with obefazimod in IBD

Abivax receives FDA agreement on pediatric development plan with obefazimod in IBD

The FDA agreed on the initial Pediatric Study Plan (iPSP) for the development of obefazimod in children aged 2 to 17 years with inflammatory bowel diseases (IBD)

Abivax global Phase 3 clinical program (ABTECT program) with obefazimod for the treatment of ulcerative colitis (UC) is ongoing with the first patient enrolled in the US on October 11, 2022

PARIS, France, December 20, 2022 06:00 p.m. (CET) Abivax SA (Euronext Paris: FR0012333284 ABVX), a Phase 3 clinical-stage biotechnology company focused on developing therapeutics that modulate the immune system to treat patients with chronic inflammatory diseases, today announced that the US Food and Drug Administration (the FDA) provided their agreement on the initial Pediatric Study Plan (iPSP) for the development of obefazimod in ulcerative colitis in children from 2 to 17 years old.

Following completion of End of Phase 2 Meeting, Abivax initiated a Phase 3 program (ABTECT program) with obefazimod in adults with moderate to severe ulcerative colitis, which includes patients aged 16 and over. Recognizing the impact of IBD in children and adolescents, Abivax is further committed to the pediatric development of obefazimod, starting with ulcerative colitis. 

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: The FDA agreement on the pediatric plan for obefazimod in IBD is an important step for Abivax to establish a wholistic and comprehensive development plan that includes an adult patient population as well as children and adolescents suffering from these diseases. Ulcerative colitis or Crohns disease often occur at a young age and may have a heavy impact on the quality of life and also on the general health and wellbeing of children and teenagers. With obefazimod, Abivax is committed to developing an efficient treatment option for these younger patients.

Obefazimod for the treatment of adults with moderate to severe ulcerative colitis

Obefazimod is currently in Phase 3 clinical trials for the treatment of ulcerative colitis (ABTECT program) with the first patient enrolled in the United States on October 11, 2022.

1,200 UC patients across 36 countries will take part in the pivotal Phase 3 program that consists of two induction trials (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106)) and a single subsequent maintenance trial (ABX464-107).

The ABTECT program aims to confirm obefazimods potential to maintain and further improve patient-outcomes over time, as well as its favorable safety and tolerability profile, as already observed during previously conducted Phase 2a and Phase 2b clinical trials in moderate to severe UC.

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About Abivax (www.abivax.com)

Abivax is a Phase 3 clinical stage biotechnology company, focused on developing therapeutics that modulate the immune system to treat patients with chronic inflammatory diseases. Abivax, founded by Truffle Capital, is listed on Euronext compartment B (ISIN: FR0012333284 Mnémo: ABVX). Based in Paris and Montpellier, Abivaxs lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of ulcerative colitis. 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 dEnregistrement 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.