Abivax completes enrollment for study of ulcerative colitis candidate
Abivax has completed enrollment in a phase 2b induction study for its ulcerative colitis drug candidate ABX464, according to a company press release.
The company said they successfully randomly assigned 232 patients ahead of schedule, despite challenges presented by the COVID-19 pandemic. They expect topline results to be available in the second quarter of 2021.
“With the financial resources of 84 million euros we secured over the past 6 months, Abivax is able to go full speed in advancing ABX464 into a pivotal phase 2b/3 study in Crohn’s disease and to prepare for the phase 3 clinical program in UC,” Abivax CEO Hartmut J. Ehrlich, MD, said in the release. “With ABX464 as a novel treatment with durable efficacy and a good safety profile observed in studies performed, we hope to make a real difference for patients suffering from the devastating consequences of inflammatory bowel diseases, as well as potentially other chronic inflammatory diseases.”
ABX464 achieved positive results over the course of multiple studies over the last 2 years. In study results reported earlier this year, the drug showed efficacy for up to 2 years of therapy in a phase 2a trial.
“Given the promising results so far, I am looking forward to see data from this phase 2b induction study, and I hope that they will once again confirm the safety and durability of clinical efficacy of ABX464 in UC patients, already observed in the phase 2a study,” Séverine Vermeire, MD, PhD, head of the IBD center at the University Hospitals Leuven, Belgium, and the study’s lead investigator, said in the release. ”Ulcerative colitis is a very disabling disease for patients, and the need for a durable and efficacious treatment is still very high.”