The data demonstrate clinically meaningful efficacy that was consistent across bleed locations, bleed types (spontaneous and traumatic), and dose cohorts evaluated. Based on these results, Hemab plans to advance sutacimig into a pivotal Phase 3 registration study in 2026.

“These Phase 2 results represent transformational potential for people living with Glanzmann thrombasthenia, who have waited a lifetime for a modern prophylactic treatment,” said Benny Sorensen, MD, PhD, Chief Executive Officer of Hemab. “The clinically meaningful reductions in bleeding demonstrated across this study provide compelling evidence that sutacimig could shift the treatment paradigm from reactive crisis management to prevention. We are moving forward with urgency to bring this therapy to patients who have been overlooked for far too long.””

Phase 2 Clinical Data Highlights: Hemab’s Phase 2 study of sutacimig (N=34) is intended to address a profound gap in care for GT as there are currently no effective prophylactic treatment options. Sutacimig was assessed at varying doses to determine the optimal regimen for Phase 3.