AbCellera Phase 2 ABCL635 meets endpoints: 83% cut in hot flash frequency vs 33% placebo

AbCellera Biologics Inc.

Phase 2 met primary endpoints: 8.8 mean reduction in daily moderate/severe hot flashes vs 3.5 placebo (p<0.001) at week 4 after single 600 mg dose
Frequency fell 83% vs 33% placebo (50% placebo-adjusted); severity down 58% vs 12% (46% adjusted, p<0.001)
92 postmenopausal women enrolled, 1:1 randomized; improvements in sleep and PGI-C also significant
No serious/severe AEs or discontinuations; common AEs: headache, fatigue, injection site reaction
Company plans Phase 3 validation; CMO Sarah Noonberg cites potential best-in-class single-dose relief

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