AbCellera Biologics (ABCL) Study result summary

Study design and patient population

• Randomized, double-blind, placebo-controlled, multicenter Phase II trial in 92 postmenopausal women aged 40–75 with moderate to severe vasomotor symptoms (VMS); baseline characteristics were well-matched and similar to prior studies.

• Participants received a single 600 mg subcutaneous dose of ABCL635 or placebo, with endpoints including VMS frequency, severity, patient-reported outcomes, safety, and pharmacokinetics.

Efficacy results

• ABCL635 group showed a mean reduction of 8.8 moderate/severe VMS events per day at four weeks, versus 3.5 for placebo, a placebo-adjusted difference of 5.3 events (83% reduction for ABCL635 vs. 33% for placebo).

• Severity scores decreased by 1.4 points for ABCL635 vs. 0.3 for placebo, a placebo-adjusted difference of 1.1 points (58% reduction for ABCL635).

• 37% of ABCL635 patients had complete resolution of moderate/severe VMS at four weeks, compared to 2.2% for placebo; 61% had at least 90% improvement.

• 84% of ABCL635 patients rated symptoms as "Much Better" or "Moderately Better" at week 4, compared to 27% for placebo.

• Improvements were consistent across subgroups and sensitivity analyses.

Patient-reported outcomes and quality of life

• ABCL635 led to significant improvement in sleep disturbance scores at week four, with a treatment difference of -5.5 to -9 points compared to placebo, benefiting all aspects of sleep.

• 71% of ABCL635 patients reported symptoms as "much better" at week four, versus 16% for placebo; 84% reported "much better" or "moderately better".

• No ABCL635 patients reported worsening symptoms; only one reported no change.