Vega Therapeutics has launched the clinical trial program for VGA039, an investigational antibody therapy for Von Willebrand disease (VWD), a bleeding disorder in which the blood does not properly clot.

The California-based clinical-stage biotech company has dosed the first subject in a phase 1 study labeled NCT05776069 with VGA039.

NCT05776069 is a multinational clinical trial being held after securing approvals of the investigational new drug application (IND) by the US Food and Drug Administration (FDA) and clinical trial application (CTA) in Europe.

The clinical trial program will start by recruiting healthy volunteers and expand to include Von Willebrand disease patients.

Gary Patou — Vega Therapeutics Chief Medical Officer said: “We are excited to advance VGA039 into the clinic as the first purpose-built antibody therapy for VWD, representing a new approach with the potential to reduce the treatment burden for these patients.

“It is our goal at Vega to enable better therapies for patients with VWD, and we are excited to have taken the first step by dosing our first subject.”

VGA039 has been designed to regulate Protein S, which is said to be a key co-factor in the generation of thrombin at the time of initiation as well as the propagation of coagulation. Preclinical evidence of its effectiveness has been shown for various congenital bleeding disorders, including Von Willebrand disease, said Vega Therapeutics.

Through the promotion of the production of thrombin by the targeting of Protein S, VGA039 is claimed to address an essential mechanism for the formation of clots in Von Willebrand disease. As a subcutaneously administered treatment, it could be able to change the course of Von Willebrand disease treatment, said Vega Therapeutics.

The biotech company stated that VGA039 could also be used to treat other bleeding disorders as well as other factors deficiencies along with platelet disorders.

The single ascending dose component in the phase 1 clinical study is intended to assess VGA039’s safety and tolerability, pharmacokinetics, and pharmacodynamic profile in healthy subjects as well as Von Willebrand disease patients.

Vega Therapeutics plans to recruit participants for the first phase of the clinical trial for VGA039 in sites in the US and other countries.

  California, Gary Patou, USA, Vega Therapeutics, VGA039, Von Willebrand disease