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AbCellera’s Menopause Antibody Hits Phase 2 Goals

Positive four-week data point to a potential monthly, non-hormonal alternative for hot flashes while larger trials and regulatory review are still required.

Overview

  • AbCellera said on Monday that a randomized, double-blind Phase 2 trial met its primary endpoints at four weeks with ABCL635 producing a placebo-adjusted reduction of about 5.3 moderate-to-severe hot flashes per day.
  • The study enrolled roughly 92 postmenopausal women and tested a single 600 mg subcutaneous dose of ABCL635, an antibody that targets the neurokinin 3 receptor.
  • Short-term safety over the four-week period was favorable with no serious or severe adverse events and the most common side effects reported as headache, fatigue, and injection-site reactions.
  • The data release drove a sharp market reaction with AbCellera’s shares jumping about 32% to close at $9.12 and intraday highs above that level.
  • AbCellera plans to publish 12-week results and must run larger, expanded efficacy trials before regulatory filing, and if results hold the treatment could provide a monthly non-hormonal option that changes choices for women who cannot or prefer not to use hormone therapy.