AbCellera Biologics Inc. (NASDAQ:ABCL) announced positive top-line Phase 2 results from its Phase 1/2 trial evaluating ABCL635.
The investigational neurokinin 3 receptor antagonist antibody is designed as a long-acting, non-hormonal subcutaneous treatment for moderate-to-severe vasomotor symptoms, or hot flashes, associated with menopause.
A single dose produced statistically significant reductions in both the frequency and severity of hot flashes at four weeks compared with placebo.
The four-week data for the Phase 2 study of ABCL635 demonstrate a new efficacy benchmark for the reduction of hot flashes both in frequency and severity, as well as improvements in sleep, said JoAnn Pinkerton, Women’s Midlife Professor of Obstetrics and Gynecology at the University of Virginia School of Medicine.
If validated in Phase 3, ABCL635 could offer a new treatment option with a more convenient dosing regimen and potentially less toxicity.
ABCL635 Phase 2 Efficacy Results
The study enrolled 92 postmenopausal women experiencing roughly 10 moderate-to-severe daily hot flashes.
Participants were divided 1:1 to receive a single 600 mg dose of ABCL635 or placebo.
By week four, ABCL635 delivered an 8.8 mean daily event reduction from baseline compared to 3.5 for placebo, yielding a placebo-adjusted difference of 5.3 events (p<0.001). This represented an 83% mean decrease in frequency for ABCL635 versus 33% for placebo, a net difference of 50%.
For symptom severity, the candidate registered a 1.4-point mean reduction at week four versus 0.3 for placebo, representing a placebo-adjusted treatment difference of 1.1 points (p<0.001).
The treatment group achieved a 58% mean reduction in severity from baseline compared to 12% in the placebo cohort, showing a net 46% advantage.
Safety Profile And Patient Outcomes
Beyond symptom relief, ABCL635 demonstrated meaningful improvements in patient sleep scores and overall patient global impression of change.
The drug was well-tolerated throughout the four weeks, with no serious or severe adverse events reported, and no study discontinuations due to adverse effects.
The primary adverse events reported more frequently than placebo were headache, fatigue, and reactions at the injection site.
ABCL Stock Price Activity: AbCellera Biologics shares were up 33.26% at $9.23 at the time of publication on Monday,
according to Benzinga Pro data.
Image via Shutterstock
Login to comment