AbCellera reports positive ABCL635 Phase 2 data, shares jump 33.26%

AbCellera Biologics Inc. reported positive top-line Phase 2 results for ABCL635, an investigational neurokinin 3 receptor antagonist antibody being developed as a long-acting, non-hormonal subcutaneous treatment (under-the-skin injection) for moderate-to-severe vasomotor symptoms, or hot flashes, associated with menopause. In a Phase 1/2 trial of 92 postmenopausal women who were experiencing roughly 10 moderate-to-severe daily hot flashes, a single 600 mg dose produced statistically significant reductions in both frequency and severity at four weeks versus placebo. Mean daily hot flash events fell by 8.8 from baseline in the ABCL635 group compared with 3.5 for placebo, for a placebo-adjusted difference of 5.3 events (p<0.001), while severity improved by 1.4 points versus 0.3 for placebo, a treatment difference of 1.1 points (p<0.001). The company also said patients showed better sleep scores and improved patient global impression of change, with no serious or severe adverse events and no discontinuations due to adverse effects during the four-week period. Women’s Midlife Professor of Obstetrics and Gynecology at the University of Virginia School of Medicine JoAnn Pinkerton said the data set a new efficacy benchmark for reducing hot flashes in both frequency and severity and improved sleep, adding that, if confirmed in Phase 3, ABCL635 could provide a more convenient dosing regimen with potentially less toxicity. AbCellera shares were up 33.26% at $9.23 at the time of publication on Monday, according to Benzinga Pro data.

The information on this website is generated using AI and we cannot guarantee its accuracy. Please use it as reference information only.