Shares of Q32 Bio (QTTB) are down 65%, following disappointing results from its SIGNAL-AD clinical trial.
SIGNAL-AD is a Phase 2a clinical trial evaluating lead drug candidate Bempikibart in adult patients with persistent, moderate-to-severe atopic dermatitis, comprising of two parts - Part A and Part B.
Part A was conducted to evaluate safety, pharmacokinetics (PK), and to enable dose selection for Part B of the clinical trial. Part B evaluated both efficacy and safety of bempikibart compared to placebo
According to results announced today, while Part A of the SIGNAL-AD trial showed promising findings, Part B did not meet its primary endpoint.
Specifically, the primary endpoint was the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score.
In Part B of the trial, patients treated with bempikibart showed a 74 percent improvement in average EASI score compared to a 76 percent improvement seen in the placebo group at Week 14.
The company also announced topline results from its Phase 2a signal-finding clinical trial evaluating bempikibart in patients with alopecia areata, dubbed SIGNAL-AA. A total of 44 patients were enrolled in this trial.
As one site was excluded from the efficacy analysis due to database lock, it led to the removal of three placebo patients. This reduced the sample size rendering the planned statistical analyses for the primary endpoint inappropriate.
However, the company noted that in a post-hoc analysis of the remaining per-protocol population of patients with alopecia areata, bempikibart showed improved hair re-growth compared to placebo.
Notably, 9 percent of bempikibart-treated patients achieved a SALT-20 response at week 24, a clinically meaningful measure of hair regrowth.
About 20 additional patients will be enrolled in a Part B expansion of the SIGNAL-AA Phase 2a clinical trial to further evaluate bempikibart in alopecia areata, the company added.
QTTB closed Tuesday's (Dec. 10, 2024) trading at $24.41, up 7.68%. In premarket trading Wednesday, the stock is down 65.5% at $8.41.
For comments and feedback contact: editorial@rttnews.com