Abivax Moving Forward with Phase 2a Clinical Trial for Ulcerative Colitis Drug

Paul Gineste, PharmD

Abivax recently announced the completion of recruitment for a phase 2b induction study testing ABX464 for patients with moderate-to-severe ulcerative colitis.

The company said the study exceeded industry standard recruitment rates for ulcerative colitis during the coronavirus disease 2019 (COVID-19) by utilizing the experience, relationships, and data built by conducting the study across many ulcerative colitis sites in conjunction with new recruitment solutions.

In the study, 232 patients were randomized ahead of schedule, with minimal impact from the ongoing pandemic on the pace of recruitment. Top-line results from the induction study, which was conducted in 15 countries in Europe, Canada, and the US, are expected to be available during the second quarter of 2021.

“The completion of recruitment of the Phase 2b induction study in ulcerative colitis with ABX464, our lead clinical program, is a critical milestone for Abivax. We are very pleased that patients enrolled so rapidly into the trial, despite the Covid-19 pandemic,” said Paul Gineste, PharmD., VP Clinical Operations of Abivax, said in a statement. “I would particularly like to thank our very committed investigators, our CRO, IQVIA, and our clinical team who made this possible, despite challenging circumstances. We are now looking forward to the high-level data that we expect will become available in Q2 2021.”

Enrollment of the phase 2b induction study first began in August 2019 and was done in conjunction with a companion long-term open-label maintenance study involving patients who have completed the induction study. In the maintenance study, which has been expanded to a second year, patients were eligible to continue the treatment.

In 2018, Abivax announced positive results of the previous phase 2a induction study testing ABX464 in patients with ulcerative colitis. This was followed by additional positive data from the 12-month open label phase 2a maintenance study.

Recently, the company confirmed positive long-term data from 2 years of dosing 50 mg ABX464. The investigators found that 69% of patients were in clinical remission after 2 years, 94% of which benefited from a clinical response.

“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 principal investigator of the study, said in a statement. “Ulcerative colitis is a very disabling disease for patients and the need for a durable and efficacious treatment is still very high.”

ABX464 is also being examined for safety and efficacy treating rheumatoid arthritis in a phase 2a proof of concept trial, with top-line results expected early in 2021.