FDA Grants Fast Track Designation to Bempikibart for Alopecia Areata

The US Food and Drug Administration (FDA) has granted the Fast Track designation to bempikibart (ADX-914) for the treatment of patients with alopecia areata, according to an announcement by Q32 Bio Inc.1

The April 30 announcement by Q32 Bio highlights the Fast Track designation by the FDA as a process crafted to facilitate the development of newer medications and allow for expedited review of such drugs. Bempikibart was designed as a fully human anti-IL-7Rα antibody, and the drug is currently being evaluated for patients with the dermatologic condition alopecia areata.

“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," Jodie Morrison, Q32 Bio’s Chief Executive Officer, said in a statement.1

In the US, approximately 7 million individuals live with alopecia areata, a hair loss disease that is known to have life-altering effects on those living with the disease as well as limited treatment options available. To address this condition, the fully human anti-IL-7Rα antibody known as bempikibart was designed to re-regulate adaptive immune function in such patients through the blockage of interleukin (IL)-7 and TSLP signaling.

The drug is being developed for the treatment of patients living with alopecia areata and is currently being assessed in phase 2 research. Now that it has been granted Fast Track designation by FDA officials, it may be 1 step closer to a potential approval in the future.

"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,” Morrison said in a statement.1 “We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients."

Medications that are given a Fast Track designation may be eligible for more frequent FDA communications, with the aim being development plan discussions and the gathering of necessary data required to support a future approval. Drugs given this designation may also be eligible for Accelerated Approval as well as Priority Review, provided the relevant criteria are met.

References

1. Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata. Q32 Bio Inc. April 30, 2025. https://ir.q32bio.com/news-releases/news-release-details/q32-bio-announces-fda-fast-track-designation-granted-bempikibart.