Revvity Signals - Drug Discovery

Q32 Bio and Horizon Therapeutics plc Announce Dosing of First Patient in Phase 2 Trial of Bempikibart (formerly ADX-914) for Severe Alopecia Areata

Thursday, September 14, 2023

Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that the first patient has been dosed in a randomized, double-blind, placebo-controlled, Phase 2 multicenter, proof-of-concept study to evaluate bempikibart in adult patients with severe alopecia areata. Q32 Bio and Horizon are collaborating to develop bempikibart, a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP, two key immune pathways.

"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," said Jodie Morrison, board member and acting chief executive officer, Q32 Bio. "Q32 Bio and Horizon are mutually dedicated to advancing bempikibart expeditiously through both Phase 2 studies."

"Alopecia areata is a complex disease with a significant unmet medical need, where patients can experience patchy or total hair loss that can impact their quality of life," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "Bempikibart represents a potential unique approach to correcting immune system dysregulation in this and other diseases."

"IL-7 is involved in the pathogenesis of alopecia areata and bempikibart has the potential to address this pathology by inhibiting IL-7Rα function and modulating T-cell responses. Bempikibart has the potential to provide long-term, durable improvement in hair loss, including the potential for disease remittance," added Jason Campagna, M.D., Ph.D., chief medical officer, Q32 Bio. "We are pleased to work alongside our partner, Horizon, to advance bempikibart to the next stage of development for patients enduring the debilitating physical and psychosocial effects of severe alopecia areata."

Alopecia areata is a common, acute onset, autoimmune disorder that affects hair follicles and is characterized by transient, non-scarring hair loss.1 It is the second most common form of alopecia and is associated with comorbidities including depression, anxiety and autoimmune diseases such as lupus erythematosus and vitiligo.2 This condition may develop at any age, disproportionately impacts women and African American populations in the U.S. and the incidence of this disease is estimated to be two percent of the population worldwide

About Q32 Bio

Q32 Bio is a clinical stage biotechnology company developing biologic therapeutics targeting potent regulators of the innate and adaptive immune systems to re-balance immunity in autoimmune and inflammatory diseases. Q32 Bio's lead programs, focused on the IL-7 / TSLP receptor pathways and complement system, address immune dysregulation to help patients take back control of their lives.

Q32 Bio Contacts:

Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
[email protected]