/ Key word(s): Study
Abivax Receives Clearance from U.S. FDA to Initiate Clinical Trials with ABX464 to treat Moderate to Severe Ulcerative Colitis
PARIS, France, January 20, 2020 - 6:30 p.m. (CET) - ABIVAX (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for their lead drug candidate ABX464, allowing the initiation of clinical trials in the U.S. in patients with moderate-to-severe ulcerative colitis (UC). The first U.S. patients are expected to be enrolled in the ongoing Phase 2b clinical trial ABX464-103, in Q2, 2020.
Under the leadership of Prof. Séverine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium, ABX464 is currently being tested in 15 European countries and in Canada in patients with moderate-to-severe UC. This ongoing Phase 2b clinical trial (ABX464-103) in 232 patients will now be extended to the U.S. Recently published data from the Phase 2a 12 months open label maintenance study showed that 75% of the patients with moderate-to-severe active UC, who had failed on immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids, were in clinical remission (meaning essentially symptom free).
In all clinical trials, ABX464 was safe and well tolerated. There were no serious adverse drug reactions reported. Adverse events were typically of mild to moderate intensity. The most common reported adverse events reported were headache, abdominal pain and diarrhea.
Prof. Hartmut J. Ehrlich, M.D., Chief Executive Officer of Abivax said: "We are very excited about the green light from the FDA, which is a very important milestone in Abivax's global development strategy for our lead compound, ABX464. By expanding the ongoing clinical Phase 2b study of ABX464 to the U.S., Abivax is aiming to make this new potential treatment option available to a substantial number of UC patients in need of new therapeutic solutions."
Prof. William Sandborn, M.D., Director of the Inflammatory Bowel Disease (IBD) Center at University of California (UC) San Diego Health and principal investigator of the trial, said: "I am pleased that this promising drug candidate can now move forward with Phase 2b testing in the U.S. Based on the data from previous trials, ABX464 has the potential to address the high unmet medical need of UC patients in the U.S. and worldwide, with many of them not responding or losing responsiveness to currently available treatments."
This press release contains forward-looking statements, forecasts and estimates with respect to certain of the Company's programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. 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 de Référence). 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.
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