Hemab Therapeutics has announced the dosing of the first patient in a Phase I/II clinical trial of its bispecific antibody HMB-001 to treat severe bleeding disorder Glanzmann Thrombasthenia (Glanzmann).
The first-in-human, open-label trial has been designed to assess HMB-001 for tolerability, safety, biomarkers such as FVII levels, and bleeding time prior to and after the treatment.
It will also evaluate the efficacy based on changes in bleeding frequency.
The trial is facilitated in partnership with Richmond Pharmacology, the UK-based clinical research organisation, and is expected to expand into other countries in the EU and the US.
Preliminary results from the trial are expected in the second half of this year.
Hemab Therapeutics CEO Benny Sorensen said: “HMB-001 is the first candidate of our emerging pipeline to reach clinical stage as we realise our mission to deliver functional cure medicines to people living with serious blood clotting disorders.
“This milestone is supported by preclinical data showing HMB-001 potentiates FVIIa-dependent fibrin formation on platelets in Glanzmann and accumulates FVIIa to levels that are considered therapeutically effective.
“We are confident clinical evaluation will confirm HMB-001’s potential and look forward to its continued clinical advancement as the first prophylaxis treatment for Glanzmann and other severe bleeding disorders.”
HMB-001 attaches, stabilises, and recruits endogenous factor VIIa to the vascular injury site to overcome the inability of the body to form healthy clots.
Last year, Hemab, along with UK’s research consultancy Haemnet, announced the commencement of a natural history study to get a better understanding of the realities of living with the disorder.
New data from the study is expected early this year.