Key Highlights

  • AbCellera's Phase 2 ABCL635 data showed statistically significant reductions in hot flash frequency and severity.
  • An 83% frequency reduction was seen versus 33% for placebo after a single 600 mg dose.
  • The data also showed improved sleep and PGI-C scores.
  • No serious or severe adverse events were reported.

AbCellera ( Nasdaq : ABCL) announced that its Phase 2 ABCL635 data in menopausal vasomotor symptoms showed statistically significant week-4 reductions in hot flash frequency and severity after a single 600 mg subcutaneous dose.

What Happened

The trial showed an 83% frequency reduction versus 33% for placebo, along with improved sleep and PGI-C scores, and no serious or severe adverse events, supporting advancement of the long-acting non-hormonal NK3R antibody into Phase 3.

A non-hormonal treatment option for menopausal vasomotor symptoms could address a significant unmet need for patients who cannot or prefer not to use hormone-based therapies, a positioning that has drawn considerable interest across the industry in this therapeutic category.

Market Reaction

The disclosed information does not include stock price or trading data for AbCellera following the Phase 2 data release.

The scale of the frequency reduction after just a single dose, together with the favorable safety profile, represents a data set that is generally viewed as supportive for progressing directly into registrational-stage development.

Outlook

Advancement into Phase 3 development for ABCL635 represents the next disclosed milestone for this non-hormonal approach to menopausal vasomotor symptoms.