Despite the failure of an eczema trial in December, Q32 Bio is sticking with bempikibart. But a phase 2-stage complement inhibitor and a number of the biotech’s “valued colleagues” won’t be so lucky.
Q32 is persevering with bempikibart, an anti-IL-7R antibody that was unable to demonstrate a reduction in eczema severity in a phase 2b study of patients with moderate to severe atopic dermatitis two months ago. Despite the company’s stock taking a hit at the time, Q32 confirmed yesterday that it will continue to investigate bempikibart in alopecia areata (AA).
The thinking behind the asset, which Q32 licensed from Bristol Myers Squibb, is that blocking the IL-7 receptor, a cytokine involved in T-cell maturation, can “tune down” the activity of T cells that attack the body’s own cells as well as those that trigger B cells to make antibodies against the body’s own tissues.
The focus on AA shouldn’t come as a surprise. Q32 tried to balance out the bad news of bempikibart’s eczema fail in December by pointing in the same release to “encouraging clinical activity” from an ongoing study of bempikibart in 44 patients with the hair loss condition.
But even on that trial, Q32 wasn’t able to chalk up a definitive win. One of the trial sites had to be excluded from the efficacy analysis “based on marked protocol violations of entry criteria,” the biotech disclosed at the time. Still, the biotech went ahead with plans to enroll another 20 patients.
In a postmarket release yesterday, Q32 CEO Jodie Morrison again pointed to the “robust pharmacologic data” from that trial as one of the reasons for the company’s conviction that bempikibart is “differentiated from existing AA therapies and has the potential to transform the treatment paradigm for this disease.”
“Further, based on the clinical characteristics of bempikibart, we continue to believe there is potential utility across additional autoimmune conditions,” Morrison added in the Feb. 10 release. “Our immediate next steps will be to extend dosing of eligible patients from SIGNAL-AA part A in an open-label extension arm and to initiate dosing of patients in the SIGNAL-AA part B clinical trial in the first half of 2025, with part B topline data expected in the first half of 2026.”
Keeping bempikibart on the road will require making some other changes to the Q32 operation. A planned phase 2 study of ADX-097, a fusion protein that targets the complement system, had already been mothballed, and the biotech said yesterday that it would also discontinue a trial in various kidney-related conditions while it “evaluate[s] strategic options for its tissue-targeted complement inhibitor platform.”
Q32—which went public last year via a merger with Homology Medicines—is also planning “a reduction in personnel and related expenses” as part of a wider plan to extend its cash runway into the second half of 2026.
“While this restructuring is a very difficult decision, it is a necessary step in the context of the evolving complement-mediated renal disease landscape and as we prioritize our focus and capital to maximize the potential of bempikibart,” Morrison said.
“Our restructuring necessitates parting with some valued colleagues, and I want to personally thank them for their dedication to our mission, commitment to patients, and their many contributions to the company,” the CEO added.
These layoffs are expected to incur severance-related charges of about $1.1 million, according to a Securities and Exchange Commission filing.
Fierce Biotech has asked Q32 how many employees are likely to be affected by the restructuring.