Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Hemab notifies positive Phase I Glanzmann thrombasthenia therapy data

HMB-001 is assessed as a prophylactic treatment for a bleeding disorder, Glanzmann thrombasthenia. Hemab Therapeutics has unveiled encouraging preliminary data from the Phase I segment of its Phase I/II trial of HMB-001, a novel bispecific antibody designed for Glanzmann thrombasthenia.

The open-label Phase I/II study aims to evaluate HMB-001's tolerability, safety, pharmacokinetics, and pharmacodynamics. The Phase I trial conducted in the UK, involved seven subjects who received subcutaneous HMB-001 at various doses.

During the 56-day observation period, HMB-001 demonstrated good tolerability, with mainly mild or moderate adverse events. No adverse events related to HMB-001 or serious adverse events were reported. Additionally, there were no dose-limiting toxicities or thromboembolic events, indicating a favourable safety profile.

Treatment with HMB-001 showed a dose-dependent pharmacodynamic effect, correlating with improvements in thrombin generation assessments. Plans are underway to expand the trial to sites in Europe and the US.