Phase 2 trails are good, AbCellera stock surges 22% on positive trial results

AbCellera (NASDAQ: ABCL) shares rose 22% Monday following positive top-line Phase 2 clinical trial results for ABCL635, an investigational treatment for moderate-to-severe vasomotor symptoms due to menopause.

The Phase 2 trial met its primary efficacy endpoints, achieving statistically significant reductions in both frequency and severity of moderate-to-severe vasomotor symptoms at week 4 compared to placebo after a single dose. The study also showed improvements in sleep and patient global impression of change.

The randomized, double-blind, placebo-controlled trial enrolled 92 postmenopausal women experiencing approximately 10 moderate or severe hot flashes per day. Participants received either a single subcutaneous 600 mg dose of ABCL635 or placebo.

ABCL635 reduced frequency of moderate-to-severe vasomotor symptoms by 8.8 events per day from baseline at week 4 compared to 3.5 for placebo, showing a placebo-adjusted treatment difference of 5.3. The treatment also reduced severity by 1.4 points at week 4 compared to 0.3 for placebo, with a placebo-adjusted treatment difference of 1.1.

ABCL635 was well-tolerated throughout the four-week treatment period with no serious adverse events, severe adverse events, or adverse events leading to study discontinuation. The most common adverse events in the ABCL635 treatment group were headache, fatigue, and injection site reaction.