SOUTH SAN FRANCISCO, Calif., June 26, 2026
Star Therapeutics announced it will present complete safety and efficacy data from its Phase 1/2 multidose clinical study evaluating VGA039 in patients with Von Willebrand disease (VWD) during the 34th International Society on Thrombosis and Haemostasis (ISTH) Congress, taking place July 11–15, 2026, in Paris, France. The presentations will include comprehensive clinical results from all enrolled patients, along with additional pharmacokinetic, pharmacodynamic, and patient experience analyses. VGA039 is currently advancing through a global Phase 3 pivotal trial and is being developed as a once-monthly subcutaneous prophylactic therapy for all types of VWD.
VGA039 Shows Promise as Once-Monthly Therapy for VWD
The featured oral presentation will highlight Phase 1/2 multidose study results demonstrating the safety profile of VGA039 and clinically meaningful reductions in bleeding episodes among patients with Von Willebrand disease, the world’s most common inherited bleeding disorder. Additional oral data will examine disease burden and prophylaxis eligibility using a large U.S. patient dataset. Poster presentations will provide new evidence supporting every-four-week subcutaneous dosing, along with qualitative research describing the experiences of adolescents, adults, and families participating in the VIVID-3 Phase 1/2 study. VGA039 is a Protein S-targeting monoclonal antibody designed to restore normal blood clotting by enhancing platelet attachment and fibrin formation through a novel mechanism of action.
Phase 3 Development Supported by Multiple FDA Designations
Building on encouraging early clinical findings, VGA039 has entered the Phase 3 VIVID-6 clinical trial (NCT07115004), evaluating monthly prophylactic treatment across all types of Von Willebrand disease. The investigational therapy has received multiple U.S. FDA regulatory designations, including Fast Track, Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease status, reflecting its potential to address a significant unmet medical need. If successful, VGA039 could become the first once-monthly subcutaneous prophylactic therapy available for patients with VWD, offering a more convenient alternative to existing factor replacement therapies that require frequent intravenous infusions.
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Incyte Acquisition Strengthens VGA039 Commercial Potential
The clinical update comes shortly after Incyte announced a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, in a transaction valued at $1.25 billion upfront, with up to $750 million in additional milestone payments, bringing the total potential value to $2 billion. The acquisition would add VGA039 to Incyte’s expanding hematology portfolio while supporting continued development of the investigational therapy. With positive clinical progress, advanced Phase 3 development, multiple FDA designations, and significant commercial backing, VGA039 is emerging as a promising next-generation treatment that could significantly improve disease management and quality of life for patients living with Von Willebrand disease.
Source: Star Therapeutics press release
