- Q32 Bio (QTTB, Financial) advances its SIGNAL-AA Phase 2a trial, dosing first patients in both Part A extension and Part B.
- Part A showed encouraging results with sustained responses up to seven months post-treatment.
- Topline data from Part B is anticipated in the first half of 2026, evaluating 20 patients over 36 weeks.
Q32 Bio Inc. (QTTB), a clinical-stage biotechnology company, has announced the dosing of the first patients in both the Part A open-label extension (OLE) and Part B of its SIGNAL-AA Phase 2a trial, evaluating the drug bempikibart in treating alopecia areata (AA). This marks a significant milestone as the company continues its efforts to develop therapies for autoimmune and inflammatory diseases.
The results from Part A of the trial indicated promising clinical activity with improvements in SALT scores and sustained SALT-20 responses through week 36. Notably, continued patient responses were observed up to week 55, approximately seven months after the last dose was administered, suggesting potential remittive effects and durability of the response.
In Part B, the trial will further assess approximately 20 patients with severe or very severe AA over a 36-week period, with follow-up extending to 52 weeks. The treatment regimen involves a 200 mg weekly loading dose for the first four weeks, followed by a 200 mg maintenance dose every other week for 32 weeks. The evaluation will focus on mean percentage changes in SALT scores and the achievement of various SALT improvements at week 36.
Q32 Bio expects to report topline data from Part B of the SIGNAL-AA trial in the first half of 2026, with plans to support advancement into pivotal trials contingent upon successful outcomes. The company aims to differentiate bempikibart as a transformative therapy in the AA treatment landscape, pending further validation of its remittive and durable effects.
