Regulators in Belgium have approved Abivax’s request for a long-term extension of the company’s ongoing Phase 2a trial of ABX464 as a treatment for ulcerative colitis.
It said it expects approvals from regulators in a number of other European countries as well.
Abiva originally developed ABX464 to treat HIV/AIDS. But it discovered that the compound had anti-inflammatory properties that could make it useful for treating inflammatory bowel diseases such as ulcerative colitis.
Preclinical-trial studies showed that ABX464 reduced inflammation and promoted gut tissue repair in mice with bowel diseaes. The protective effect on the gut continued after treatment, the studies demonstrated.
The results led to the Phase 2a proof-of-concept trial named ABX464-101 (NCT03093259) that is assessing the treatment’s safety and ability to help patients with moderate-to-severe colitis.
Researchers are continuing to enroll patients who have failed to respond to, or are unable to tolerate, other treatments, including immunomodulators, anti-tumor necrosis factor alpha (TNFa), vedolizumab and corticosteroids.
Abivax is conducting the trial at 18 centers in France, Belgium, Germany, Hungary, Poland, the Czech Republic, Spain and Austria. Participants are being randomized to receive either 50 mg of oral ABX464 or a placebo once a day for eight weeks.
Preclinical-trial studies showing that ABX464 is safe prompted regulators in Belgium to approve the idea of a long-term extension trial that involves patients who are responding to the treatment.
“We are very pleased with this first authorization for a one-year treatment with ABX464, as it validates the encouraging safety profile of our compound, and we are looking forward to receiving the approvals from additional countries in the coming weeks and months,” Dr. Hartmut Ehrlich, CEO of ABIVAX, said in a press release.
Participants in the ABX464-101 trial who decide to participate in the extension (NCT03368118) will receive 50 mg of ABX464 for 12 months. This includes patients who received either the treatment itself or the placebo in the initial trial.
“The approval of the long-term protocol marks another important step in the clinical development of ABX464,” said Dr. Ian McGowan, a gastroenterology, hepatology and nutrition professor at the University of Pittsburgh School of Medicine.
“Given the high unmet medical need in ulcerative colitis, we welcome the approval of the long-term follow-up study, allowing patients who are suffering from this devastating disease and are responding to treatment with ABX464 to continue receiving this new treatment for another 12 months,” he said.