Incyte Corporation (NASDAQ:INCY) on Monday reported complete Phase 1/2 multidose data for latarcibart (VGA039), showing substantial reductions in bleeding episodes and a favorable safety profile in patients with von Willebrand disease (VWD).
VWD is the most common inherited bleeding disorder, affecting about 1% of the population.
It is caused by a deficiency or malfunction of the von Willebrand factor, a blood protein needed for platelets to clot properly.
Bleeding Rates Fell Across Patient Groups
The analysis included all 16 enrolled patients, all of whom completed six doses of latarcibart, with maintenance treatment administered subcutaneously every four weeks as of May 5, 2026.
The investigational therapy produced a median 81% reduction in annualized bleeding rate (ABR) across all VWD types and bleeding categories, including serious gastrointestinal bleeds and hemophilia-like joint and muscle bleeds.
Among patients who transitioned from intravenous von Willebrand factor (VWF)-containing prophylaxis, bleed reductions ranged from 75% to 100%, suggesting potential improvement over the current standard of care.
For patients who had not previously received IV prophylaxis, seven entered the study with historical ABRs above 12, a key eligibility requirement for the ongoing Phase 3 VIVID-6 trial.
In this subgroup, ABR reductions ranged from 46% to 100%, while six of the seven patients achieved reductions greater than 73%.
Monthly Therapy Shows Favorable Safety Profile
Latarcibart also reduced VWF-treated breakthrough bleeds by approximately 86%.
Additionally, 70% of patients who had previously required VWF treatment for breakthrough bleeding experienced no such events while receiving the therapy.
According to the company, every participant who entered the study with a significant bleeding burden elected to continue treatment in the ongoing open-label extension study.
The once-monthly subcutaneous therapy was reported to be safe and well-tolerated.
Investigators recorded three treatment-emergent adverse events related to latarcibart, including two Grade 2 headaches in one patient and one Grade 1 injection-site reaction.
One unrelated serious adverse event involving severe gastrointestinal bleeding occurred in a patient with a history of frequent and severe GI bleeding.
Therapy Advances Following Acquisition
Latarcibart targets Protein S to improve hemostasis and is currently in pivotal Phase 3 development for VWD. If approved, it could become the first once-monthly subcutaneous prophylactic treatment for the inherited bleeding disorder, offering an alternative to frequent intravenous replacement factor infusions.
Incyte acquired VGA039 (latarcibart) in July 2026 through its acquisition of Vega Therapeutics Inc., a wholly owned subsidiary of Star Therapeutics LLC.
INCY Stock Price Activity: Incyte shares were down 0.61% at $116.00 during premarket trading on Monday, according to Benzinga Pro data.
Photo: Faces Portrait/Shutterstock
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