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Q32 Bio Announces Completion of Enrollment in the SIGNAL-AD Phase 2 Clinical Trial of Bempikibart for Atopic Dermatitis

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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).

Positive
  • 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.
Negative
  • None.

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 --

WALTHAM, Mass., July 9, 2024 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that it has completed enrollment in the SIGNAL-AD Phase 2 clinical trial of bempikibart (ADX-914) for the treatment of persistent, moderate-to-severe atopic dermatitis (AD). Bempikibart is a fully human anti-IL-7Rα antibody that is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, both of which contribute to inflammation and injury in a diversity of autoimmune disorders. 

"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 the United States. In individuals with AD, the immune system is overactive, triggering inflammation that damages the skin barrier. 

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

Availability of Other Information About Q32 Bio

Investors and others should note that we communicate with our investors and the public using our company website www.Q32Bio.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Forward-Looking Statements 

This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations and financial condition, and our expectations regarding the timing and data from our Phase 2 clinical trials for bempikibart in AA and AD in the fourth quarter of 2024.

Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to integrate our business with our merger partner successfully and to achieve anticipated synergies; the possibility that other anticipated benefits of the merger will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of our operations, and the anticipated tax treatment of the merger; our ability to retain, attract and hire key personnel; potential adverse reactions or changes to relationships with employees, suppliers or other parties resulting from the completion of the merger;  potential business uncertainty, including changes to existing business relationships that could affect our financial performance; the need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; our product candidates may cause serious adverse side effects; the inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties, including for the manufacture of materials for our research programs, preclinical and clinical studies; failure to obtain U.S. or international marketing approval;  ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; securities class action litigation;  the impact of global pandemics and general economic conditions on our business and operations, including the our preclinical studies and clinical trials; the possibility of system failures or security breaches; risks relating to intellectual property; significant costs incurred as a result of operating as a public company; and such other factors as are set forth in Q32 Bio's periodic public filings with the SEC, including but not limited to those described under the heading "Risk Factors" in our Form 10-Q for the quarter ended March 31, 2024 filed on May 9, 2024. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Contacts: 

Investors: Brendan Burns 
Media: Sarah Sutton 
Argot Partners 
212.600.1902 
Q32Bio@argotpartners.com 

Q32 Bio Logo (PRNewsfoto/Q32 Bio)

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SOURCE Q32 Bio

FAQ

What is Q32 Bio's latest update on the SIGNAL-AD clinical trial?

Q32 Bio has completed patient enrollment for the SIGNAL-AD Phase 2 trial of bempikibart, exceeding the target with 121 patients. Topline results are expected in Q4 2024.

What is bempikibart and its purpose in the SIGNAL-AD trial?

Bempikibart is a fully human anti-IL-7Rα antibody aimed at regulating immune function to treat atopic dermatitis (AD).

When will the SIGNAL-AD Phase 2 trial results be available?

Topline results from the SIGNAL-AD Phase 2 trial are expected to be released in the fourth quarter of 2024.

How many patients were enrolled in the SIGNAL-AD trial?

The SIGNAL-AD trial enrolled a total of 121 patients, surpassing the initial target of approximately 100 patients.

What other trials has Q32 Bio announced recently?

Q32 Bio has also completed enrollment for the SIGNAL-AA Phase 2 trial for severe alopecia areata (AA).

What is the primary endpoint of the SIGNAL-AD Phase 2 trial?

The primary endpoint is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score.

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