Incyte to buy Vega, assume VWD treatment development
Phase 3 trial of monthly injection therapy VGA039 currently recruiting patients
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Incyte will acquire Vega Therapeutics, a subsidiary of Star Therapeutics, to advance the development of VGA039, an investigational monthly injection therapy to prevent bleeds in people with von Willebrand disease (VWD).
VGA039 is being evaluated as a prophylactic (preventive) treatment option for VWD in the VIVID-6 Phase 3 clinical trial (NCT07115004). The study is recruiting up to 60 people with any type of VWD, ages 12-75, with at least 12 bleeds per year, at sites in the U.S., Germany, Georgia, and South Africa.
“VGA039 fits directly into our strategy of building a top-tier growth company for the future,” Bill Meury, CEO of Incyte, said in a company press release. “It is a first-in-class, Phase 3 asset with compelling early data, a manageable development path and the potential to become an important new growth driver in one of our core therapeutic areas – hematology.”
Adam Rosenthal, PhD, founder and CEO of Star, agreed. “VGA039 will be advanced by Incyte, a global biopharmaceutical leader with deep expertise in hematology and a significant commercial track record,” Rosenthal said.
The most common inherited bleeding disorder, VWD is caused by low levels of or defects in von Willebrand factor (VWF), a protein that helps blood clot. VWD symptoms can include frequent nosebleeds, easy bruising, heavy menstrual bleeding, and prolonged bleeding after injury, surgery, or dental procedures.
Monthly injection on FDA approval fast track
A standard VWD treatment to prevent bleeds is factor replacement therapy, which provides patients with a functioning version of VWF. While effective, replacement therapies often require multiple intravenous (into-the-vein) infusions per week, which can be taxing for some patients.
VGA039 is administered monthly by subcutaneous (under-the-skin) injections. It works by targeting Protein S, a natural anticoagulant protein, to improve hemostasis, the process that helps the body stop bleeding.
The drug has received several U.S. Food and Drug Administration designations, holding breakthrough therapy, rare pediatric disease, fast track, and orphan drug statuses. These programs are intended to support the development of treatments for serious conditions and rare diseases.
Interim data from 16 VWD patients participating in an ongoing Phase 1/2 VIVID trial (NCT05776069) showed that monthly VGA039 injections were well tolerated and markedly reduced bleeding rates.
Among people previously on intravenous prophylaxis, switching to VGA039 reduced bleeding rates by 75% to 100%. For those not on prophylaxis and with at least 12 bleeds per year, bleeding rates dropped by 73% to 87%.
Building on these findings, Star launched the Phase 3 VIVID-6 study to assess VGA039’s efficacy and safety in about 60 adolescents and adults with VWD. Eligibility criteria exclude patients who had been receiving preventive factor replacement therapy in the six months preceding the study.
Participants will be observed for 24 weeks (about six months) without the study drug before receiving once-monthly subcutaneous injections of VGA039 for approximately 49 weeks (about one year).
The study’s main goal is to reduce bleeding events during treatment with VGA039 over 49 weeks. Secondary measures include the incidence of treated bleeding events, blood VGA039 levels, and the occurrence of anti-drug antibodies that may reduce treatment effectiveness.
Under the terms of the acquisition, Star will receive an upfront payment of $1.25 billion, which could increase to as much as $2 billion if certain sales milestones are met. The companies expect the transaction to close later this year, subject to regulatory review and other conditions.
“This milestone reflects our team’s deep commitment to innovation and underscores our strategy to develop first-in-class and best-in-class therapies for serious conditions with high unmet need,” Rosenthal said. “I am immensely proud of the Star Therapeutics team and our work toward making a difference for patients with von Willebrand disease.”
