#United States #Waltham #Q32 Bio #Bempikibart #Alopecia Areata

Q32 Bio Announces Strategic Restructuring

Waltham, MA - In a significant move, Q32 Bio Inc., a clinical-stage biotechnology firm, has revealed its intention to restructure operations. The focus will shift towards propelling the development of its leading candidate, bempikibart, for the treatment of alopecia areata (AA).

The Road Ahead with Bempikibart

Recent data from the SIGNAL-AA Part A clinical trial highlights promising results for bempikibart, showcasing strong re-consent rates and an evident demand among patients for ongoing treatment. Consequently, Q32 Bio will initiate an open-label extension in the first half of 2025, allowing eligible patients from the trial to continue their treatment. Furthermore, the Phase 2 part B of the clinical trial is set to commence within the same timeline, with topline data anticipated in early 2026.

Q32 Bio’s Chief Executive Officer, Jodie Morrison, expressed the company's confidence that bempikibart could redefine treatment standards for alopecia areata. Preliminary results from the ongoing studies reflect marked improvements in patients’ conditions, as evidenced by reductions in the Severity of Alopecia Tool (SALT) scores. These results have been consistent, including observable benefits several months post-treatment, suggesting a strong therapeutic effect.

Decision to Discontinue ADX-097 Trials

Despite the encouraging trajectory of bempikibart, the company has opted to discontinue a Phase 2 renal basket trial for ADX-097. This decision aims to conserve resources while strategizing the future of its complement inhibitor platform. Morrison acknowledged the difficulty of this choice, especially as it entails parting ways with valued team members who have contributed significantly to their mission.

Financial Outlook and Strategic Options

Looking ahead, the company's financial runway has now been projected to span until the second half of 2026, enabling them to concentrate on advancing the bempikibart program while also preserving necessary resources for future endeavors.

Bempikibart's Development Program

The ongoing clinical development of bempikibart has demonstrated notable pharmacological activity, alongside a manageable safety profile. With a focus on autoimmune diseases, this treatment could cater to a wider range of patients, potentially influencing future therapeutic strategies across various conditions. The strategic restructuring is not merely a reaction to recent developments but aligns with broader objectives to optimize their research and development capacities in the biotechnology landscape.

Insights into Ongoing Trials

The upcoming SIGNAL-AA Part B will explore the efficacy of bempikibart over a 36-week treatment period, encompassing both initial high-dosing and maintenance phases. Researchers anticipate that this trial will provide additional clarity and data to propel bempikibart into later-stage trials, contingent upon the outcome.

Conclusion

As Q32 Bio remains steadfast on its newfound trajectory, the biotechnology firm continues engaging with its stakeholders and the public through various channels, ensuring that updates on the bempikibart program and overall strategic direction are transparently communicated. With the restructuring in place, Q32 Bio aims to bolster its commitment to groundbreaking therapies for autoimmune conditions, enhancing patients' lives in the process.

For further details about Q32 Bio’s initiatives, please visit www.Q32Bio.com.

Forward-Looking Statements

This announcement may contain forward-looking statements regarding Q32 Bio's objectives and outcomes. Investors are encouraged to monitor the company’s communications for any updates that could affect their ongoing and future clinical trials.