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news.Star Therapeutics' investigational monoclonal antibody, VGA039, has gained fast track designation from the US Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD).
The therapy offers ‘convenient’ dosing regimen minimising the treatment burden for individuals. Credit: CDC on Unsplash.
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The ‘fully human’, immunoglobulin G4 (IgG4) antibody is tailored to target Protein S, aiming to restore balance in blood clotting and potentially serves as a ‘universal haemostatic therapy’ for various bleeding disorders.
It is poised to be the ‘first subcutaneous therapy’ for all types of VWD, offering a ‘convenient’ dosing regimen that could minimise the treatment burden for individuals.
In June last year, the company announced the clinical data from the Phase I clinical trial, VIVID 1, of the therapy in healthy volunteers. The findings showed a ‘favourable’ tolerability and safety profile of the therapy.
By adjusting the cofactor function for tissue factor pathway inhibitor α (TFPIα) and activated protein C (aPC), the therapy aims to enhance and restore thrombin generation, which is essential for clot formation.
Star Therapeutics founder and CEO Adam Rosenthal said: “VGA039 is the first drug candidate to receive Fast Track designation for VWD, and we are committed to advancing drug innovation for this debilitating disease that has lagged behind other bleeding disorders.
“Fast Track designation enables us to potentially accelerate the development path for VGA039 as a therapy that can transform the way VWD is treated with a convenient, subcutaneous therapy for patients with all types of VWD.”
This designation is aimed at facilitating the development and expediting the review process of drugs that address serious conditions and fulfil an unmet medical need.
South San Francisco based biotechnology company, Star Therapeutics focuses on developing antibodies for haematology and immunology and is supported by various life sciences investors.
