Denmark-based clinical-stage biotechnology company Hemab Therapeutics announced on Friday interim data from the ongoing assessment of HMB-001, a bispecific antibody in development as first ever prophylactic treatment for the bleeding disorder Glanzmann thrombasthenia (GT).
The Phase 2 study consists of a minimum 6-week prospective run-in where participants record bleeds via an electronic bleed diary, followed by 3 months of treatment with HMB-001. Interim efficacy data to date demonstrated >50% reduction in treated bleeds in all 3 tested dose cohorts.
Underscoring its potential to address unmet medical needs and to expedite patient access, HMB-001 has been granted Orphan Drug Designation by the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency has awarded it designation under the Innovative Licensing and Access Pathway.
Hemab also unveiled compelling preclinical data for HMB-002, a potential novel treatment for Von Willebrand Disease (VWD). These data were featured as oral presentations at the 18th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) held last week in Milan, Italy. The company is planning to complete the phase two study recruitment in the first half of 2025.
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