Abivax has enrolled the first patients in its global phase 3 clinical programme, ABTECT, with obefazimod for the treatment of moderate to severe ulcerative colitis (UC), the company announced.
UC is an inflammatory bowel disease which causes the immune system to begin attacking the gut, resulting in swelling and inflammation in the rectum and colon. Approximately one in every 227 people in the UK is diagnosed with UC, and half of those in England with UC have a moderate to severe form of the condition.
The programme aims to confirm the promising results from the company’s phase 2b open-label maintenance study of a once-daily 50mg dose of oral obefazimod.
These results, as well as 48-week extension results of obefazimod in UC, have recently been scientifically validated and published as an article in The Lancet Gastroenterology and Hepatology, the company reported.
Abivax outlined that 1,200 UC patients will take part in the phase 3 programme, consisting of two induction studies and a single subsequent maintenance study.
The primary efficacy endpoint, assessed at week eight in the induction and at week 44 in the maintenance study, will be clinical remission according to the modified Mayo Score, as required by US Food and Drug Administration.
So far, more than 460 study sites, out of the targeted 600 sites, have been qualified to take part in the phase 3 trials.
“We are very happy that our pivotal global phase 3 programme has successfully started in the US with the enrolment of the first patient. Our focus is now to timely complete the recruitment of UC patients into the two induction studies for which the top-line results are expected for the end of 2024,” said Professor Hartmut Ehrlich, chief executive officer of Abivax.
Ehrlich also outlined the company’s plans to “swiftly” request market authorisations in the US and in Europe once the required data is available.
“As a practising gastroenterologist, I am confronted every day with the high unmet medical need for safe therapies that have long-term efficacy and convenient administration for patients with UC. I am optimistic that the ABTECT programme will confirm obefazimod’s potential to address these medical needs,” said Professor Bruce Sands, the Dr Burrill B Crohn professor of medicine at the Icahn School of Medicine at Mount Sinai, chief of the Henry D Janowitz Division of Gastroenterology at Mount Sinai, and principal investigator of the studies in the US.