Enrollment completed in phase 2 trial of bempikibart for atopic dermatitis treatment

Key takeaways:

• Enrollment was not only completed but also exceeded the target goal of 100 patients.
• The phase 2 trial is split into two parts, with the first evaluating safety and the second efficacy.

Enrollment has been completed in a phase 2 clinical trial for the evaluation of bempikibart as a treatment for adults with persistent, moderate to severe atopic dermatitis, Q32 Bio announced in a press release.

Bempikibart (ADX-914) is a fully human anti-interleukin-7RA antibody that may block inflammatory signaling found in autoimmune disorders.

According to the release, enrollment in the two-part, randomized, double-blind, placebo-controlled, phase 2 SIGNAL-AD trial exceeded the initial target of 100 patients due to a patient demand to enter part B of the trial. Ultimately, 121 patients were enrolled, with 15 entering part A of the trial.

"We are grateful to the patients and their clinical teams whose high level of interest enabled us to complete enrollment on schedule while exceeding our original target enrollment," Jason Campagna, MD, PhD, chief medical officer of Q32 Bio, said in the release. "We believe that this demand speaks to both the enthusiasm following completion of part A of the trial and the unmet need for patients with AD."

While part A of the clinical trial has already been completed, the results are still blinded. In this first section of the trial, the safety and pharmacokinetics of bempikibart were evaluated, and dose selection was determined for part B of the trial.

In part B, patients have been randomly assigned to receive 200 mg of the drug or placebo once every 2 weeks for 12 weeks. Researchers will evaluate the drug’s efficacy based on the mean percent change in EASI scores from baseline to week 14. Following treatment completion, patients will be observed for another 12 weeks.

Trial data are expected in the fourth quarter of 2024.