Q32 Bio and Horizon Therapeutics plc 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-7Ra antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP, two key immune pathways. Alopecia areata is a common, acute onset, autoimmune disorder that affects hair follicles and is characterized by transient, non-scarring hair loss.

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. 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. Bempikibart (formerly ADX-914) is a fully human anti-IL-7Ra antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP.

Q32 Bio has completed a biomarker-enabled Phase 1 study characterizing the pharmacokinetics, pharmacodynamics and safety of bempikibart in healthy volunteers. Q32 has initiated Phase 2 trials in atopic dermatitis and alopecia areata.