AbCellera Biologics Inc. announced positive top-line results from the Phase 2 clinical trial of its investigational antibody, ABCL635, for treating moderate-to-severe vasomotor symptoms (hot flashes) due to menopause. The study met its primary endpoints, showing statistically significant reductions in both the frequency and severity of hot flashes after a single dose compared to placebo.
Key Details
- Efficacy (Frequency): At week 4, ABCL635 reduced the frequency of moderate-to-severe hot flashes by 83% from baseline, compared to a 33% reduction for placebo (p<0.001).
- Efficacy (Severity): The severity of hot flashes was reduced by 58% in the ABCL635 group versus 12% in the placebo group at week 4 (p<0.001).
- Safety Profile: ABCL635 was well-tolerated with no serious or severe adverse events reported in the treatment group. The most common adverse events were headache, fatigue, and injection site reaction.
- Additional Outcomes: The trial also demonstrated significant improvements in patient sleep scores and overall impression of change. The company plans to discuss late-stage development with regulators.