Oral drug shows efficacy up to 2 years in refractory UC
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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.”
Perspective
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Benjamin Cohen, MD, MAS
The article presents results from the open label maintenance phase for ABX464, which was previously an induction study that included 232 patients. It showed promising results from the induction phase and this was a limited subset of that study. In the current analysis, the investigators looked at 22 patients during long-term maintenance with once daily 50 mg dosing. It was promising that 19 of the 22 patients were able to maintain on treatment at one year and 16 at two years. The high percentage of patients remaining on long-term therapy indicates good durability with clinical response. Importantly, nearly half were in endoscopic remission as well. These are impressive results for maintenance therapy which will hopefully translate to positive results in the larger randomized controlled phase 2b trial which is ongoing. However, it’s important to keep in perspective that maintenance studies only include patients who initially responded to induction and are not reflective of what we should expect in patients newly starting therapy. Still, the good long-term efficacy signal, lack of serious adverse events, and oral delivery make this an attractive molecule to follow in larger ulcerative colitis clinical trials.
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