Q32 Bio Completes Enrollment in SIGNAL-AD Phase 2 Trial of Bempikibart for Atopic Dermatitis

Q32 Bio Inc., a biotechnology company focused on developing biologic therapeutics to restore immune balance, has successfully completed enrollment for its SIGNAL-AD Phase 2 clinical trial evaluating bempikibart (ADX-914) for moderate-to-severe atopic dermatitis (AD). This trial aims to advance treatments for a condition that affects over 25 million people in the United States.

Bempikibart is a fully human anti-IL-7Rα antibody designed to modulate immune function by inhibiting IL-7 and TSLP signaling pathways, both of which contribute to inflammation in various autoimmune diseases. The completion of enrollment was ahead of schedule, driven by high patient interest, with the total number of participants reaching 121, surpassing the original target of approximately 100 patients. Jason Campagna, Chief Medical Officer of Q32 Bio, expressed gratitude toward the patients and clinical teams, emphasizing the strong demand for such treatments and the enthusiasm generated by the trial's initial phase.

The SIGNAL-AD trial is structured in two parts. Part A focused on assessing the safety and pharmacokinetics (PK) of bempikibart and facilitated dose selection for Part B. Although the data from Part A remains blind, Part B is now underway to evaluate the efficacy and safety of bempikibart compared to a placebo. In this phase, participants are divided equally between receiving a 200 mg dose of bempikibart biweekly and a placebo, with the treatment period lasting 12 weeks. The primary measure of success is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score. Following the treatment, patients will continue to be monitored for another 12 weeks. The topline results from both parts of the trial are anticipated to be shared in the fourth quarter of 2024.

Jodie Morrison, CEO of Q32 Bio, highlighted the significance of this accomplishment, noting that the company has also completed enrollment for its SIGNAL-AA Phase 2 trial in severe alopecia areata (AA), marking another key milestone. The company is eager to reveal the topline data from both trials later this year.

Atopic dermatitis, the most common form of eczema, involves an overactive immune system leading to skin inflammation and barrier damage. Bempikibart's role in blocking IL-7 and TSLP signaling is crucial, as these pathways are implicated in numerous T cell-mediated autoimmune conditions.

Q32 Bio is also pursuing another Phase 2 trial for bempikibart in alopecia areata, a condition characterized by severe hair loss. The company's focus on rebalancing the immune system extends to their program for innate immunity, ADX-097, which aims to regulate the complement system without long-term systemic effects. This program has already completed a Phase 1 trial in healthy volunteers.

Q32 Bio is committed to developing innovative therapies addressing both the innate and adaptive immune systems to treat autoimmune and inflammatory diseases. Their efforts in modulating immune pathways such as IL-7/TSLP and the complement system are designed to help patients manage their conditions more effectively. The company’s advancements in these areas represent a significant step towards offering new hope for patients with challenging autoimmune conditions.