Star Therapeutics Receives FDA Fast Track Designation for VGA039 in Von Willebrand Disease (VWD)

VGA039 is potentially the first subcutaneous therapy that addresses all types of VWD and has a convenient dosing regimen

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Star Therapeutics, a clinical stage biotechnology company discovering and developing best-in-class antibodies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VGA039 in von Willebrand disease (VWD). VGA039 is an investigational monoclonal antibody that targets Protein S to restore balance in blood clotting, as a universal hemostatic therapy for numerous bleeding disorders. It is potentially the first subcutaneous therapy that addresses all types of VWD and has a convenient dosing regimen.

“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,” said Adam Rosenthal, Ph.D., CEO and Founder of Star Therapeutics. “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.”

The FDA grants investigational medicines Fast Track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate’s development plan in addition to a rolling submission of the marketing application. Product candidates with Fast Track designation may also be eligible for priority review and accelerated approval.

About VGA039

VGA039 is a monoclonal antibody therapy with a novel mechanism of action that targets Protein S, a key component in restoring balance to the blood clotting process. VGA039 has potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, with the first disease indication of von Willebrand disease (VWD). As a subcutaneously self-administered antibody therapy with a convenient dosing regimen, VGA039 has the potential to dramatically reduce treatment burden for patients.

About Star Therapeutics

Star Therapeutics is a clinical stage biotechnology company discovering and developing best-in-class antibodies to create life-changing therapies for patients, initially addressing unmet needs in hematology and immunology. The company applies its expertise in antibody innovation to interrogate areas of biology that have been overlooked and have the potential for addressing multiple diseases with a single therapy. Star is backed by leading life sciences investors and located in South San Francisco. For more information, please visit Star Therapeutics and follow us on LinkedIn.