Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months
|
EQS-News: ABIVAX
/ Key word(s): Miscellaneous
Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months
PARIS, France, January 22, 2024, 8:30 a.m. CET – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today provides an outlook on its 2024 strategic priorities and milestones. Marc de Garidel, Chief Executive Officer of Abivax, says: “We are on track to deliver our strategic roadmap as laid out in September last year to prepare obefazimod for commercialization if approved, starting with ulcerative colitis in the US. Our US office has recently been opened and we have completed the recruitment of a very experienced team with a particular focus in the US. For 2024, our priority stays on the completion of patient recruitment into the ABTECT Phase 3 induction trials.” Didier Blondel, Chief Financial Officer of Abivax, adds: “With the successful Nasdaq IPO in October 2023, the largest ever Nasdaq IPO of a French-listed biotech company, we expect to be fully financed through the planned data read-outs of the UC and CD induction trials. In parallel, we continue to implement our multi-pronged financing strategy to fund our ambitious projects in 2024 and beyond, with the objective to increase shareholder value.”
Obefazimod Phase 3 program in UC (ABTECT) The obefazimod Phase 3 ABTECT program investigating efficacy and safety in adults with moderately to severely active UC is progressing. Recruitment into both induction trials, ABTECT-1 and ABTECT-2, is ongoing in all designated regions. The ABTECT program is designed for 1,200 UC patients across 36 countries in over 600 trial sites to take part in the pivotal Phase 3 program that covers North America, Europe, Latin America and Asia Pacific. Clinical remission is the primary endpoint for the eight-week induction trials as well as for the maintenance trial at week 52 (which is week 44 of the maintenance trial). Anticipated milestones:
Objectives:
UC patients initially treated with 50 mg of oral, once-daily obefazimod and who completed the Phase 2a or Phase 2b maintenance trials could roll over into a follow-on, open-label maintenance trial with a reduced dose of 25 mg. In an interim analysis as of July 31, 2023, of the 71 eligible patients, 63 completed their 48-week visit, with a demonstrated disease control rate (stable or improved Modified Mayo Score) of 84% (53 of 63 patients) with the 25 mg once-daily dose of obefazimod. No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod. Anticipated milestones:
Objectives:
Based on existing supportive preclinical and clinical Inflammatory Bowel Disease (IBD) data, Abivax is advancing obefazimod in a Phase 2 trial in moderately to severely active Crohn’s disease (CD). Anticipated milestones:
Objectives:
Anticipated Milestones:
Objectives:
Crohn’s and Colitis Congress (Jan. 25-27, 2024, Bellagio, Las Vegas, US)
19th Congress of European Crohn’s and Colitis Organisation (Feb. 21-24, 2024, Stockholm, Sweden)
Digestive Disease Week (May 18-21, 2024, Washington, D.C., US)
Abivax successfully completed its initial public offering on the Nasdaq Global Market in October 2023, raising USD 235.8 million in gross proceeds (app. USD 212.2 million in net proceeds) under challenging market conditions:
Objectives:
Financial Agenda:
A webcast will be organized following the publication of the annual financial results
***** About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases. Based in France and the US, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @ABIVAX.
This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “continue,” “could,” “design,” “expect,” “goal,” “intend,” “objective,” “plan,” “potential,” “project,” ”will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax's drug candidate, Abivax’s expectations regarding the availability of data and timing of reporting results from its clinical trials, including its Phase 3 ABTECT-1 and ABTECT-2 induction trials, obefazimod extension trials in UC, and obefazimod Phase 2 trial in CD, the availability and timing of preclinical data to support decision-making on therapy candidates for use in combination with obefazimod in UC, as well as the availability and timing of disclosure of preclinical data of any such combination therapy, the selection of an obefazimod follow-on drug candidate from Abivax’s miR-124 library, and enrollment of patients in clinical trials, Abivax’s plans to strengthen its product pipeline with additional opportunities to use obefazimod in a combination therapy and additional compounds in the field of chronic inflammatory diseases, Abivax’s cash runway and strategy to extend its cash runway, and other statements that are not historical fact. 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). 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. 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 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.
22.01.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
Editor Details
-
Company:
- EQS Newsfeed
- Website:
