Bempikibart - (SIGNAL-AA)
- Indication
- Alopecia areata (AA)
- Stage
- phase2
- Event
- Topline Data
- Details
May 5, 2026: Q32 Bio Inc. (NASDAQ: QTTB) reported Q1 2026 financial results and provided a corporate update centered on bempikibart (ADX-914) for alopecia areata (AA). The company said Part B of the SIGNAL-AA Phase 2a open-label trial remains on track, with a 36-week topline data readout expected in mid-2026; Part B is evaluating bempikibart in 33 patients with severe/very severe AA (current episode up to four years) using a loading regimen (200 mg weekly x4) followed by 200 mg every other week through week 36, with follow-up to week 52. Efficacy assessments include mean % change in SALT score and proportions achieving SALT improvements at week 36. Q32 noted encouraging clinical activity to date and preliminary PK suggesting steady-state was reached at least nine weeks earlier vs Part A. The first patient was dosed in the Part B open-label extension (OLE). The Part A OLE is complete, and findings are planned to be reported alongside Part B 36-week topline results in mid-2026.
Financing: completed a $10.5M registered direct offering (February 2026) and reported $50.8M cash as of March 31, 2026 (excluding $14.2M ATM proceeds received after quarter-end); runway expected into 1H 2028 including near-term milestone payments from the ADX-097 asset sale.
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