Q32 Bio still sees potential for its anti-IL-7R antibody as an alopecia treatment despite failing a phase 2 eczema study—but investors appear unconvinced.
The biotech—which went public earlier this year via a merger with Homology Medicines—had been evaluating bempikibart in a phase 2b study of 106 patients with moderate to severe atopic dermatitis. The study failed to show that a 200-mg subcutaneous dose of the drug every other week was able to reduce eczema severity or size after 14 weeks compared to placebo.
Specifically, patients treated with bempikibart showed a 74% improvement in their average eczema size and severity score, compared to 76% for the placebo cohort.
In a statement, CEO Jodie Morrison said the company was “disappointed” by the results and would conduct a review to better understand the data, “including the high placebo rate.”
Q32 balanced out the bad news by referring to “encouraging clinical activity” from an ongoing study of bempikibart in 44 patients with alopecia. Individuals treated with the drug showed a 16% reduction in hair loss compared with a 2% reduction in the placebo group at Week 24, the biotech pointed out. By Week 26, 13% of patients who received bempikibart achieved an alopecia scalp hair loss score of 20, compared to none of the patients on placebo.
But even on this 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, meaning three placebo patients were removed from the trial and the primary endpoint couldn’t be assessed as planned.
Investors also seemed unimpressed, sending the biotech’s stock down 65% to $8.55 in premarket trading Wednesday from a Tuesday closing price of $24.41.
Still, the company is planning to enroll another 20 patients in the alopecia trial, which Chief Medical Officer Jason Campagna, M.D., Ph.D., said had already “showed clinically meaningful activity and a safety profile that we believe is differentiated from the currently approved therapies.”
Expanding the alopecia trial will come at the expense of a planned phase 2 study of ADX-097, a fusion protein that targets the complement system, in ANCA-associated vasculitis that had been due to kick off next year. ADX-097 is already being evaluated in an ongoing phase 2 trial for renal diseases.
Q32 licensed bempikibart from Bristol Myers Squibb. The thinking behind the asset is that blocking the IL-7 receptor, a cytokine involved in T-cell maturation, could “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.