WALTHAM, Mass., July 13, 2026. Q32 Bio Inc. reported 36-week topline results Monday from Part B of its SIGNAL-AA Phase 2a trial evaluating bempikibart in patients with severe or very severe alopecia areata, a milestone the company has been building toward since completing enrollment of the expanded cohort earlier this year.

Bempikibart, also known as ADX-914, is a fully human antibody targeting the IL-7 receptor alpha, designed to re-regulate adaptive immune function by blocking both IL-7 and TSLP signaling. Part B of the trial enrolled 33 patients with severe or very severe alopecia areata and a maximum current episode duration of four years, treating them with bempikibart for 36 weeks with follow-up extending to 52 weeks. Efficacy was assessed using mean percentage change from baseline in Severity of Alopecia Tool scores, along with the proportion of patients achieving various relative and absolute SALT improvements at week 36.

The Part B protocol used an optimized dosing regimen, an initial loading phase of 200 milligrams administered weekly for four doses followed by 200 milligrams every other week for 32 weeks, that Q32 Bio said achieved steady-state drug concentrations at least nine weeks earlier than in Part A of the trial. The company has said it believes the faster pharmacokinetic profile has the potential to produce earlier clinical responsiveness than was observed in the trial’s first phase.

“There remains significant need for safer and more durable therapies in AA, and we believe bempikibart has the potential to transform the treatment paradigm,” said Jodie Morrison, chief executive officer of Q32 Bio, ahead of Monday’s data disclosure. Alopecia areata affects an estimated 700,000 people in the United States and can have a significant psychological impact on patients, many of whom have limited treatment options beyond the handful of JAK inhibitors approved in recent years.

The FDA has granted bempikibart Fast Track designation for alopecia areata, a status intended to expedite the drug’s development and review timeline. Part A of the SIGNAL-AA trial continues to generate longer-term data through an open-label extension study initiated last year, which the company says has shown a remittive effect and durable treatment responses, with strong patient demand supporting continued dosing in that extension cohort.

Q32 Bio has narrowed its pipeline sharply around bempikibart over the past year, selling its Phase 2 complement inhibitor ADX-097 to Akebia Therapeutics in a deal that could bring the company up to 592 million dollars in development, regulatory and commercial milestones plus tiered royalties. Combined with a 10.5 million dollar registered direct offering completed in February, the company has said it has cash runway into the fourth quarter of 2027, giving it room to advance bempikibart toward pivotal trials pending review of Monday’s Part B results.