Denmark-based clinical-stage biotechnology company Hemab Therapeutics on Monday reported positive results from the completed Phase 2 multiple ascending dose (MAD) portion of its CL-101 study of sutacimig intended for the prophylactic treatment of Glanzmann thrombasthenia (GT), a severe bleeding disorder marked by debilitating, sometimes life-threatening bleeding episodes.

The data, presented in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, demonstrate clinically meaningful efficacy that was consistent across bleed locations, bleed types (spontaneous and traumatic), and dose cohorts evaluated. Based on these results, Hemab says that it plans to advance sutacimig into a pivotal Phase 3 registration study in 2026.

Hemab's Phase 2 study of sutacimig (N=34) is intended to address a gap in care for GT as there are currently no effective prophylactic treatment options.