AbCellera Announces 'Striking' Phase 2 Data for ABCL635 in Vasomotor Symptoms Due to Menopause

AbCellera announced positive top-line Phase 2 data for ABCL635, a non-hormonal, long-acting antibody targeting the neurokinin 3 receptor (NK3R) for moderate-to-severe vasomotor symptoms (VMS) due to menopause (hot flashes).

The randomized, double-blind, placebo-controlled Phase 2 portion (NCT07118891) enrolled 92 postmenopausal women with a mean of ~10 moderate or severe hot flashes per day; participants received a single subcutaneous 600 mg dose of ABCL635 or placebo.

ABCL635 met primary endpoints with statistically significant (p<0.001) reductions from baseline at week 4 in both frequency and severity of moderate-to-severe VMS compared to placebo.

For VMS frequency, ABCL635 showed a mean reduction of 8.8 events per day versus 3.5 for placebo (placebo-adjusted difference: 5.3; mean percent reduction: 83% vs. 33%, difference:
50%).

For VMS severity, ABCL635 showed a mean reduction of 1.4 points versus 0.3 for placebo (difference: 1.1; mean percent reduction: 58% vs. 12%, difference:
46%).

Statistical significance in both frequency and severity was maintained from week 1 through week 4 (p<0.001).

ABCL635 also produced meaningful improvements in patient sleep scores and patient global impression of change (PGI-C).

The drug was well-tolerated over four weeks with no serious adverse events, severe adverse events, or discontinuations due to adverse events; most common treatment-related adverse events were headache, fatigue, and injection site reactions.