Abivax receive EMA scientific advice support for ulcerative colitis trial

pharmafile | January 13, 2022 | News story | Business Services  

Abivax have received scientific advice from the EMA supporting advancing ABX464 into Phase III clinical testing, for the treatment of ulcerative colitis, and for subsequent potential marketing authorisation submission and commercialisation.

“Abivax is very happy with the outcomes of the regulatory consultations as they pave the way for finalizing an appropriate study design that will be crucial to confirm the benefit of ABX464 for the efficient and durable treatment of ulcerative colitis,” Prof Hartmut J. Ehrlich, MD, CEO of Abivax, said. “Given the impressive phase 2a and phase 2b study results, especially with respect to long-term clinical remission data, we believe that our drug candidate can make a real difference to improve the lives of the many patients suffering from ulcerative colitis. I am looking forward to sharing our latest achievements and plans as part of my presentation at the J.P. Morgan Healthcare Conference with the investors and the pharmaceutical community.”

The advice received from the EMA supports moving ABX464 into a pivotal Phase III programme in ulcerative colitis, with no concerns raised regarding clinical safety, non-clinical safety, or CMC. FDA feedback given in November 2021, and the EMA scientific advice, are both largely consistent. Abivax is currently reviewing suggested modifications. Both the FDA and EMA agreed that Abivax progressing 25mg and 50mg into Phase III testing is appropriate, for induction and the subsequent maintenance studies in UC.

Ulcerative colitis is a long-term condition, in which the colon, or the large intestine, and rectum become inflamed. Small ulcers can develop on the colon’s lining, and can bleed and produce pus. The main symptoms of ulcerative colitis include recurring diarrhoea, which may contain blood, mucus or pus; tummy pain; needing to empty bowels frequently; and high levels of fatigue, alongside loss of appetite and weight loss.

Ana Ovey

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