Q32 Bio Announces Completion of Enrollment in the SIGNAL-AD Phase 2 Clinical Trial of Bempikibart for Atopic Dermatitis
Q32 Bio announced the completion of patient enrollment for its SIGNAL-AD Phase 2 clinical trial of bempikibart for atopic dermatitis (AD). The trial surpassed its target, enrolling 121 patients due to high demand. Bempikibart is an anti-IL-7Rα antibody aimed at regulating immune function to combat AD. The trial consists of two parts: Part A for safety and dose selection, and Part B for efficacy and safety comparison with placebo. Topline results are expected in Q4 2024. This milestone follows the completion of another Phase 2 trial for alopecia areata (AA).
- Exceeded enrollment target with 121 patients in the SIGNAL-AD trial.
- Topline results of SIGNAL-AD and SIGNAL-AA Phase 2 trials expected in Q4 2024.
- Completion of two critical milestones in 2024 with both Phase 2 trials.
- None.
Insights
The completion of enrollment for Q32 Bio's Phase 2 clinical trial of bempikibart for atopic dermatitis signals a key milestone for the company. The increased enrollment to 121 patients, surpassing initial targets, highlights significant patient and clinician enthusiasm. This enthusiasm might be linked to the unique mechanism of action of bempikibart, which targets IL-7 and TSLP signaling pathways—both important in mediating inflammation and autoimmune responses.
For investors, the timely completion of enrollment and the expected release of topline results in Q4'24 provides a clear timeline for the next catalyst. Given that atopic dermatitis affects over 25 million people in the U.S., the market potential for an effective treatment is substantial. However, the efficacy and safety data will be pivotal. Investors should watch for the Eczema Area and Severity Index (EASI) score changes, as this is the primary endpoint for the trial and a significant indicator of clinical benefit.
While the news is encouraging, it is worth noting that the data remains blinded and the ultimate success of bempikibart depends on positive efficacy and safety outcomes. The high unmet need in the atopic dermatitis market and the novel approach of bempikibart offer potential, but risks remain until conclusive data is available.
The announcement's financial implications are notable for Q32 Bio. Exceeding the enrollment target indicates robust interest and could signal strong demand if bempikibart proves effective. The timing of the topline results release in Q4'24 also provides a clear marker for potential stock price movement. Positive Phase 2 results often lead to significant stock appreciation, especially in the biotech sector.
However, investors should be cautious. The costs associated with clinical trials are substantial and the company's financial health must be scrutinized to ensure it can sustain its operations until potential commercialization. Additionally, while the increased enrollment is a positive sign, it also means higher trial costs, which could impact the company's short-term financials.
Long-term investors should consider the broader market for atopic dermatitis treatments. The existing competition includes well-established players with approved treatments. Bempikibart's unique mechanism could offer a competitive edge, but only if it demonstrates superior efficacy and safety.
-- Exceeded enrollment target due to patient demand; trial size increased to 121 patients --
-- Bempikibart topline results remain on track to be released in Q4'24 --
"We are grateful to the patients and their clinical teams whose high level of interest enabled us to complete enrollment on schedule while exceeding our original target enrollment," said Jason Campagna, M.D., Ph.D., Chief Medical Officer of Q32 Bio. "We believe that this demand speaks to both the enthusiasm following completion of Part A of the trial and the unmet need for patients with AD."
"In addition to completing enrollment in SIGNAL-AD, we previously announced that enrollment in the SIGNAL-AA Phase 2 clinical trial in severe alopecia areata (AA) is also complete, marking the achievement of two critical milestones this year," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We are thrilled with our continued progress advancing bempikibart and we look forward to sharing topline data from both Phase 2 clinical trials in the fourth quarter of this year."
SIGNAL-AD (NCT05509023) is a two-part Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in adult patients with persistent, moderate-to-severe AD. Part A was conducted to evaluate safety, PK, and to enable dose selection for Part B of the clinical trial. Part A was completed, but data remains blinded. Part B is being conducted to evaluate the efficacy and safety of bempikibart as compared with placebo. In Part B, patients were enrolled 1:1 in the bempikibart 200 mg Q2W SC flat dose and placebo arms for 12 weeks of treatment. The primary endpoint is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score. Patients will be followed for an additional 12 weeks following completion of treatment.
A total of 121 patients were enrolled, including 15 patients in Part A. Total enrollment exceeded the initial target of approximately 100 patients due to Part B patient enrollment demand. Topline data from Parts A and B are expected in the fourth quarter of 2024.
AD is the most common type of eczema and affects more than 25 million people in
About Bempikibart
Bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody that is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. Q32 Bio is currently evaluating bempikibart in two ongoing Phase 2 clinical trials: SIGNAL-AD, a Phase 2 study in patients with atopic dermatitis (AD) and SIGNAL-AA, a Phase 2 study in patients with alopecia areata (AA).
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's program for adaptive immunity, bempikibart (ADX-914), is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases. It is being evaluated in two Phase 2 trials for the treatment of atopic dermatitis and alopecia areata. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases. Q32 Bio's program for innate immunity, ADX-097, is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade – a key differentiator versus current complement therapeutics. Q32 Bio has completed a first-in-human, Phase 1 ascending dose clinical study of ADX-097 in healthy volunteers.
For more information, visit www.Q32Bio.com.
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Contacts:
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Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
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