FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

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Q32 Bio, of Waltham, Mass., announced on April 30, 2025 that its human anti-IL-7Rα antibody, bempikibart (ADX-914), has been given fast track designation by FDA for the treatment of alopecia areata (AA) (1).

According to the National Alopecia Areata Foundation (NAAF), a California nonprofit, AA is a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (“alopecia” means bald, and “areata” means patchy) (2). In severe cases, total hair loss is possible. NAAF said about 2% of the world population will experience AA, meaning approximately 700,000 people in the United States currently have AA in some form. More than 80% of those with the disease exhibit signs before age 40, with women more likely to develop it than men, and Asian, Black, and Hispanic populations having higher odds than whites.

As a fully human antibody, bempikibart re-regulates adaptive immune function, according to Q32 Bio, by blocking the IL-7 and TSLP pathways that have been genetically and biologically implicated as forces behind T cell-mediated pathological processes in various autoimmune diseases (1). Q32 Bio’s ADX-914 candidate, currently in development, is being evaluated in a Phase II trial.

FDA’s fast track process facilitates development and expedites review of new drugs that are intended to treat serious diseases and fill an unmet need, all with the goal of getting those drugs to patients faster (1). Drugs that receive a fast track designation may also be eligible for accelerated approval and priority review from FDA if certain criteria are met.

"The fast track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart's potential as a novel, differentiated therapy for patients needing new options," said Jodie Morrison, chief executive officer of Q32 Bio, in a company press release (1). "This fast track designation follows the encouraging clinical activity observed in Part A of our SIGNAL-AA clinical trial and the recent initiation of dosing in the Part A open-label extension and Part B portions of the SIGNAL-AA trial. We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients."

Alopecia areata was one of the diseases addressed at the March 2025 meeting of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use. At that time, an application for an initial marketing authorization was withdrawn for Cinainu (liquid ethanolic extract 30% [W/W] of Allium cepa fresh bulb and citrus limon fresh fruit/dry aqueous extract of paullinia cupana seed/dry hydroethanolic extract of theobroma cacao seed), an herbal medicine developed by Switzerland-based Legacy Healthcare for treatment of moderate-to-severe AA (3). No further details on the withdrawal were given, except for that Legacy took the action in February 2025 following a re-examination, according to EMA.

References

1. Q32 Bio. Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata. Press Release. April 30, 2025.
2. Alopecia Areata. National Alopecia Areata Foundation | NAAF. NAAF.org (accessed April 30, 2025).
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.