Oral drug shows efficacy up to 2 years in refractory UC
ABX464, a once-daily, oral treatment for ulcerative colitis, showed efficacy for up to 2 years of therapy in a phase 2a trial, according to the drug’s manufacturer Abivax.
In the study, researchers randomly assigned patients with UC who were refractory or intolerant to at least one existing treatment to receive either ABX464 or placebo in an initial induction phase. For the maintenance phase, they enrolled 22 patients in the 50 mg once-daily open label study.
At 52 weeks, 19 patients remained on treatment, and 16 of those patients completed 2 years of therapy.
Researchers found that 69% of patients were in clinical remission and 94% achieved clinical response, while 44% achieved endoscopic remission, defined as an endoscopic Mayo score of zero.
The drug was also well tolerated by patients, and none prematurely discontinued therapy due to an adverse event during the 2-year study. Investigators observed no serious adverse events.
“We are very excited about the 2-year open label phase 2a maintenance results, which provide further momentum for our clinical development efforts with ABX464 to address the high unmet medical need in UC,” Harmut J. Ehrlich, MD, CEO of Abivax, said in a press release. “These recent findings reinforce the potential of ABX464 as a well-tolerated and efficacious once-daily oral therapy for patients with moderate-to-severe ulcerative colitis.”