Abivax will present the complete results of its Phase 2a trial ABX464-101 (NCT03093259) and interim results of the open-label extension study ABX464-102 (NCT03368118). Both aimed to assess the safety and efficacy of ABX464 as a treatment for ulcerative colitis.
The data will be presented at the 14thCongress of the European Crohn’s and Colitis Organization (ECCO) March 6-9 in Copenhagen, Denmark. The oral presentation is titled “ABX464 is safe and efficacious in a proof of concept study in ulcerative colitis patients.”
“We are very pleased that our abstract has been selected as a plenary presentation by ECCO’s scientific program committee,” Jean-Marc Steens, chief medical officer of Abivax, said in a press release. “This is a great scientific validation of the importance of these data and we are eager to share these promising results with the medical community, including many key [inflammatory bowel disease] specialists who may be interested to participate in our upcoming Phase 2b clinical trial.”
Ulcerative colitis is an inflammatory disease that causes ulcerations on the rectum and colon. For many patients, there are limited treatment options.
ABX464 is a small molecule first developed to reduce viral load in HIV-positive people. However, it also showed strong and long-lasting anti-inflammatory properties in a mouse model for colon inflammation.
During the ABX464-101 study, 32 patients with moderate to severe ulcerative colitis were treated either with ABX464 or a placebo, and the effects were evaluated for two months. The trial showed positive results as the treatment was safe, well-tolerated, and led to clinical remission in 35% of patients compared to 11% in the placebo group.
The ongoing ABX464-102 trial is evaluating the long-term effect of ABX464 in 22 patients who participated in the ABX464-101 trial, 15 treated with the therapy and seven on placebo. The study will last one year; partial results from the first six months will be presented at ECCO.
“Patients with this devastating disease are in urgent need of innovative treatments, as too many of them do not respond or stop responding to current drugs,” said Hartmut J. Ehrlich MD., CEO of Abivax.
Abivax focuses on therapies that strengthen the immune system to treat inflammatory and autoimmune diseases, viral diseases, and cancer. It currently is testing the effects of ABX464 on several diseases.
“We are dedicated to advancing the clinical development of ABX464 in ulcerative colitis as well as in other inflammatory diseases including Crohn’s disease and rheumatoid arthritis,” Ehrlich said.