GlobeNewswire·Nov 9, 2026, 7:00 AM ET

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

COAG

Hemab Therapeutics initiated the SOLARA Phase 3 trial for sutacimig (HMB-001) to evaluate its efficacy as a once-weekly subcutaneous prophylactic treatment for Glanzmann thrombasthenia (GT).
The trial involves approximately 75 participants aged 12 to 70 years and follows a single-arm design with a 24-week run-in period followed by 48 weeks of treatment.
The primary endpoint is the annualized treated bleed rate (ATBR) during the treatment period compared to the run-in period, where participants continue standard on-demand care.
Sutacimig is a bispecific antibody designed to stabilize endogenous Factor VIIa and recruit it to activated platelets to compensate for platelet dysfunction.
Phase 2 data presented at the ISTH 2026 Congress showed a 62% reduction in mean high-intensity annualized treated bleed event rates among participants with prior high-intensity bleeding.
Three Grade 2 thromboembolic events occurred in earlier trials; the SOLARA dose regimen was selected to optimize bleed reduction while avoiding high peak exposures linked to these events.
The FDA recommended a randomized controlled design but acknowledged feasibility challenges in this rare disease, allowing Hemab to proceed with the single-arm intra-participant comparison.
No approved prophylactic therapies currently exist for GT, a disorder where 88% of patients reported at least one bleed in the previous week according to the Glanzmann's 360 natural history study.
Sutacimig holds Fast Track, Orphan Drug, Breakthrough Therapy, and PRIME designations from U.S. and European regulators for the treatment of GT.
Participants completing the 48-week treatment period may enroll in a separate open-label extension study to continue sutacimig therapy.

Company: Hemab Therapeutics, Inc.
Keywords: Nasdaq:COAG, Hemab Therapeutics, Inc.