Abivax has completed patient enrollment, ahead of schedule and despite the COVID 19 pandemic, in its Phase 2b trial evaluating ABX464 as a treatment candidate for people with moderate-to-severe ulcerative colitis (UC).
Top-line results are expected by June 2021, the company announced.
The trial, called ABX464-103 (NCT03760003), has enrolled a total of 232 adults with moderate-to-severe UC. It is being conducted across multiple clinical sites in 15 European countries, the U.S., and Canada.
“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,” Paul Gineste, Pharm D, vice president of clinical operations of Abivax, said in a press release.
“I would particularly like to thank our very committed investigators, our CRO [contract research organization], 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,” Gineste added.
ABX464 is an oral small molecule that promotes the production of a microRNA, called miRNA-124, which has strong anti-inflammatory activity.
MicroRNAs are tiny RNA molecules that regulate gene expression, or activity, within cells. They bind to a particular gene’s messenger RNA (mRNA) — the molecule generated from DNA and used as the template for protein production — to prevent the generation of that protein.
The ongoing ABX464-103 trial is assessing the safety and effectiveness of three daily doses of ABX464 (25, 50, or 100 mg) versus a placebo in patients with moderate-to-severe UC. After completing the trial, participants have the option to enroll in an open-label extension study, called ABX464-104 (NCT04023396), that will investigate the therapy’s long-term effectiveness and safety.
In the extension study, participants will receive 50 mg of ABX464 daily irrespective of their previous dose. The trial, originally designed to last one year, has been expanded for a second year. To date, 130 out of the 132 patients who completed ABX464-103 have enrolled in the open-label trial.
Previous one-year data from the Phase 2a ABX464-101 trial (NCT03093259) showed that ABX464 led to clinical remission in 75% of the patients who had moderate-to-severe active UC. These findings were further confirmed in its open-label extension study, called ABX464-102 (NCT03368118), in which ABX464 continued to induce clinical remission over the course of two years.
In the open-label study, 69% of patients achieved clinical remission and 94% responded to treatment with ABX464.
“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,” said Séverine Vermeire, MD, PhD, head of the IBD Center at the University Hospitals Leuven, Belgium, and the trial’s principal investigator.
“Ulcerative colitis is a very disabling disease for patients and the need for a durable and efficacious treatment is still very high,” Vermeire said.
Abivax also is testing ABX464 as a potential treatment for people with moderate-to-severe Crohn’s disease in a Phase 2a trial (NCT03905109).
Further, the therapy is being investigated for patients with COVID-19 in a Phase 2b/3 clinical trial (NCT04393038) underway in Europe, the U.K., Brazil, and Mexico, and for people with rheumatoid arthritis in a Phase 2a trial (NCT03813199). Top-line results on both of these trials are expected in 2021.
“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,” said Hartmut J. Ehrlich, MD, CEO of Abivax.
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