Abivax announced that its oral ulcerative colitis drug candidate met the clinical and endoscopic endpoints of a phase 2a trial.
Following the positive results, the company will launch a phase 2b dose-ranging study of the drug, ABX464, according to a press release.
“These results have exceeded our expectations given the statistically significant, strong efficacy already observed in this phase 2a study, in patients refractory to available therapies including anti-TNF monoclonal antibodies,” Jean-Marc Steens, MD, chief medical officer of Abivax, said in the release. “They validate our hypothesis that ABX464 novel mechanism of action would result in potent anti-inflammatory properties in patients.”
Abivax recruited 32 patients from 15 centers across Europe to participate in the trial. The patients all had moderate to severe UC who did not respond to immunomodulators, anti-tumor necrosis factor-alpha, Entyvio (vedolizumab, Takeda) and/or corticosteroids.
Investigators randomly assigned patients 2:1 to 50 mg ABX464 or a placebo once daily for 8 weeks. Twenty-nine patients completed the study.
Researchers found that a higher percentage of patients in the ABX464 group achieved clinical remission (35% vs. 11%), mucosal healing (50% vs. 11%) and clinical response (70% vs. 33%) compared with patients in the placebo group, according to the press release.
Additionally, investigators found that ABX464 was safe and well tolerated, with no severe adverse events reported.
“Based on these exciting results, Abivax will initiate, without delay, a phase 2b dose-ranging study in Europe, with potential input from U.S. [key opinion leaders] and FDA on study design,” Hartmut Ehrlich, MD, CEO of Abivax, said in the press release. “Furthermore, these data strongly encourage us to pursue phase 2 clinical trials in other inflammatory indications including Crohn’s disease.”
Abivax has plans to present the full study data at upcoming scientific conferences, as well as submit them for publication, according to the release.
Disclosures: Steens and Ehrlich are employed by Abivax.