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Hemab Therapeutics Initiates SOLARA, a Pivotal Phase 3 Trial of Sutacimig in Glanzmann Thrombasthenia

COAG
  • Hemab Therapeutics has initiated the SOLARA Phase 3 trial, the first pivotal study to evaluate once-weekly subcutaneous sutacimig for prophylactic treatment of Glanzmann thrombasthenia (GT).
  • The single-arm trial enrolls approximately 75 participants aged 12 to 70 years, with first participants scheduled to enter the run-in period in Q4 2026.
  • The trial design features a 24-week run-in period where patients continue standard on-demand care, followed by a 48-week treatment period involving sutacimig injections.
  • The primary endpoint is the annualized treated bleed rate (ATBR) during the treatment period compared to the run-in period.
  • Phase 2 data showed treated bleed rates fell in 92% of participants, with a 62% reduction in high-intensity bleed events among those with prior high-intensity bleeding.
  • Three Grade 2 thromboembolic events occurred in Phase 2, leading to the selection of a dose regimen in SOLARA optimized to avoid high peak exposures.
  • The FDA acknowledged Hemab's rationale for the single-arm design despite recommending a randomized controlled trial, citing feasibility challenges in the rare GT population.
  • Sutacimig is a bispecific antibody with Fast Track, Orphan Drug, and Breakthrough Therapy designations from the FDA for GT treatment.
  • No approved prophylactic therapies currently exist for GT, a disorder affecting platelet function with significant impacts on daily life and mental health.
  • Participants completing the 48-week treatment period may enroll in a separate open-label extension study for continued access to sutacimig.