Star Therapeutics Presents Clinical Data for VGA039, a Subcutaneous Therapy for the Treatment of Von Willebrand Disease (VWD)
2024年6月26日 - 8:00PM
ビジネスワイヤ(英語)
VGA039 clinical data supports favorable safety
profile in healthy volunteers and convenient subcutaneous dosing
regimen
Oral presentation delivered at International
Society on Thrombosis and Haemostasis (ISTH) Congress
Next stage of VIVID clinical program underway
in VWD patients
Star Therapeutics, a clinical stage biotechnology company
discovering and developing best-in-class antibodies, today
announced the presentation of clinical data from VIVID 1 (VGA039
Investigation in Von Willebrand Disease), a Phase 1 clinical study
of VGA039 in healthy volunteers. VGA039 is designed to be a
universal hemostatic therapy for numerous bleeding disorders and
potentially the first subcutaneous therapy for von Willebrand
disease (VWD). The VGA039 clinical data was presented today in an
oral presentation at the 32nd Congress of the International Society
on Thrombosis and Haemostasis (ISTH), taking place on June 22-26 in
Bangkok, Thailand.
The data reported from the VIVID clinical program are from the
first part of the study in healthy volunteers (VIVID 1) with the
next part of the program underway in VWD patients (VIVID 2) in the
multinational Phase 1 study of VGA039 (NCT05776069). The Phase 1
results in healthy volunteers demonstrated pharmacokinetics and
pharmacodynamics for VGA039 that support convenient subcutaneous
dosing and showed nearly 100% subcutaneous bioavailability, with a
favorable safety and tolerability profile.
“We welcome the ongoing progress of VGA039 as the potential
first subcutaneous treatment for VWD to reduce the substantial
treatment burden that currently impacts VWD patients and families,”
said Jeanette Cesta, Executive Director, VWD Connect Foundation.
“We join the patient community in encouraging the advancement of
new treatments that continue to bring us hope for the future.”
The oral presentation at ISTH 2024 Congress includes these key
findings:
- VGA039 was safe and well-tolerated with intravenous (IV) and
subcutaneous (SC) administrations of single ascending doses in
healthy volunteers.
- No serious or thromboembolic adverse events (AEs) were
observed.
- No infusion-related or injection site reactions were
observed.
- Dose-proportional increases in VGA039 concentration were
demonstrated in both IV and SC cohorts.
- VGA039 showed nearly 100% SC bioavailability, with a half-life
(t1/2) of 25 days.
- VGA039 demonstrated dose-dependent increases in thrombin
generation and other pharmacodynamic biomarkers.
In previously reported results in an oral presentation at the
American Society of Hematology (ASH) annual meeting in December
2022, VGA039 demonstrated in vivo efficacy in a VWD non-human
primate model. In additional studies using patient samples, VGA039
demonstrated in vitro the ability to restore thrombin generation in
numerous bleeding disorders, supporting the potential of VGA039 to
be effective as a universal hemostatic agent. Star Therapeutics’
VGA039 is being developed through the company’s Vega therapeutic
group.
“We are delighted to present these first clinical data for
VGA039. VGA039’s high subcutaneous bioavailability and favorable
pharmacokinetic profile supports convenient subcutaneous dosing for
VWD prophylaxis,” said Gary Patou, M.D., Chief Medical Officer of
Star Therapeutics. “We are excited to continue moving ahead with
our VIVID clinical program of VGA039 in VWD patients.”
About VGA039 VGA039 is a fully human, IgG4 monoclonal
antibody therapy with a novel mechanism of action that modulates
Protein S, a key cofactor involved in thrombin generation. By
attenuating Protein S cofactor function for tissue factor pathway
inhibitor α (TFPIα) and activated protein C (aPC), VGA039 augments
and restores thrombin generation during both initiation and
propagation of coagulation, addressing fundamental mechanisms of
clot formation. VGA039 has potential to be a universal hemostatic
therapy that can treat numerous bleeding disorders, including von
Willebrand disease. As a subcutaneously self-administered antibody
therapy with convenient dosing, VGA039 has the potential to
significantly reduce treatment burden for patients.
About von Willebrand disease Von Willebrand disease (VWD)
is a bleeding disorder in which the blood does not clot properly.
In VWD, defective or low amounts of von Willebrand factor (VWF)
lead to insufficient platelet adhesion and unstable clot formation.
VWD causes severe bleeding that can damage organs and lead to
significant impact on patients’ daily lives. Current therapies for
VWD prophylaxis include factor replacement requiring frequent
intravenous (IV) infusions multiples times every week.
About the VIVID Clinical Program The VIVID (VGA039
Investigation in Von Willebrand Disease) clinical program is a
platform multiphase protocol for the development of VGA039 in Von
Willebrand disease. VIVID 1 is the single ascending dose study in
normal healthy volunteers and VIVID 2 is the single ascending dose
study in VWD 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.
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Media Kathryn Morris, The Yates Network LLC 914-204-6412
kathryn@theyatesnetwork.com