Q32 Bio Inc. (NASDAQ:QTTB) stock is trading higher on Monday after the clinical-stage biotechnology company shared positive 36-week topline results from Part B of its Phase 2a SIGNAL-AA trial.
The data showed that bempikibart produced clinically meaningful hair regrowth in patients with severe or very severe alopecia areata while maintaining a favorable safety profile.
The company said the data support advancing the antibody into a registration-directed program during the first half of 2027.
Hair Regrowth Seen Across Multiple Efficacy Measures
Part B enrolled 33 patients with baseline Severity of Alopecia Tool (SALT) scores between 50 and 100, including individuals previously treated with oral JAK inhibitors.
Alopecia areata is an autoimmune disease where the immune system mistakenly attacks hair follicles, causing hair to fall out in round, coin-sized patches on the scalp, face, or body.
The trial’s primary endpoint evaluated the mean percentage change in SALT scores from baseline in the modified intent-to-treat population.
At Week 36, patients achieved a mean 35.3% reduction in SALT scores.
Among modified intent-to-treat patients, 40% achieved a SALT-20 response, while 44% reached both SALT30 and SALT50 response thresholds.
In the intent-to-treat population, 30.3% achieved SALT-20, with 33.3% reaching both SALT30 and SALT50.
The company said responses were observed in patients with both severe and very severe disease.
Early follow-up data also suggested durability, with several patients maintaining or improving hair regrowth after treatment ended, including one patient who achieved complete hair regrowth.
Safety Profile Remained Consistent
Q32 Bio said bempikibart continued to demonstrate a generally well-tolerated safety profile consistent with previous studies.
No treatment-related serious adverse events or Grade 3 or higher adverse events were reported.
The study also showed favorable pharmacokinetic, pharmacodynamic, and anti-drug antibody findings. According to the company, the loading-dose regimen achieved steady-state drug concentrations about 10 weeks earlier than in Part A, while anti-drug antibody levels remained negligible.
Extension Study Supports Maintenance Dosing
Q32 Bio also reported results from the completed open-label extension of SIGNAL-AA Part A. Eight patients, including prior responders, non-responders, and placebo recipients, re-entered treatment after being off therapy for 26 to 55 weeks.
The company said patients who had maintained hair growth before re-treatment generally preserved or further improved their results during the extension, while the safety profile remained consistent with no new concerns.
QTTB Stock Price Activity: Q32 Bio shares were up 71.90% at $19.27 during premarket trading on Monday, according to Benzinga Pro data.
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