First Patient Dosed in Phase 2 Trial of Bempikibart for Alopecia Areata

Q32 Bio and Horizon Therapeutics plc recently announced that the first patient has been dosed in the randomized, placebo-controlled phase 2 study (NCT06018428) evaluating bempikibart (formerly ADX-914) in adults with severe alopecia areata (AA).¹ Bempikibart is a fully human anti-interleukin-7Rα antibody that reregulates adaptive immune function by interfering with signaling mediated by interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP).

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SIGNAL-AA is a double-blind, multi-center, proof of concept phase 2 study evaluating the drug. Patients will receive the drug or placebo subcutaneously every 2 weeks for 24 weeks with 12 weeks of follow-up. Q32 is also in phase 2 trials for treatment of atopic dermatitis.²

The IL-7 and TSLP receptor pathways have been shown tobe drivers in several T cell-mediated pathological processes in many autoimmune diseases, such as AA. The phase 1 study demonstrated the pharmacokinetics, pharmacodynamics, and safety of bempikibart in healthy volunteers.¹

"Given the biology implicated in alopecia areata, we believe ADX-914 is a novel approach to addressing the underlying disease process. We believe treatment with ADX-914 could allow for an exceptionally strong and durable clinical response," Jason Campagna, MD, PhD, and chief medical officer of Q32 Biotold Dermatology Times."¹

Q32 Bio and Horizon Therapeutics announced their collaboration and option agreement to develop bempikibart for treating autoimmune diseases in August 2022. Under the agreement, Horizon will fund development through completion of 2 phase 2 trials of bempikibart. Q32 Bio is responsible for conducting activities related to the program.¹

"Dosing of the first patient in the phase 2 study in alopecia areata, in addition to our ongoing Phase 2 study in atopic dermatitis, demonstrate the breadth of potential applications of bempikibart and our deep commitment to transform the lives of patients with autoimmune and inflammatory diseases," Jodie Morrison, board member and acting chief executive officer, Q32 Bio said in a news release.

References

1. Q32 Bio and Horizon Therapeutics plc announce dosing of first patient in phase 2 trial of bempikibart (formerly ADX-914) for severe alopecia areata. News release. September 13, 2023. Accessed September 13, 2023. https://prnmedia.prnewswire.com/news-releases/q32-bio-and-horizon-therapeutics-plc-announce-dosing-of-first-patient-in-phase-2-trial-of-bempikibart-formerly-adx-914-for-severe-alopecia-areata-301925655.html
2. Randomized, double-blind, placebo-controlled phase 2a, proof-of-concept trial of ADX-Phase 2a trial for the treatment of severe alopecia areata (SIGNAL-AA). Clinicaltrials.gov. Updated August 30, 2023. Accessed September 13, 2023. https://clinicaltrials.gov/study/NCT06018428