Veloxis Pharmaceuticals announced today that its lead transplant candidate, VEL-101, has received official recognition from the United States Adopted Name (USAN) Council, which has approved "pegrizeprument" as the drug's nonproprietary name. This designation represents a significant step forward as the company prepares to advance the novel immunosuppressive agent into the next phase of clinical development.
The USAN Council, comprising experts from the American Medical Association, the U.S. Pharmacopeial Convention, and the Food and Drug Administration, establishes standardized drug nomenclature to facilitate clear communication among healthcare professionals, researchers, and patients worldwide.
"The adoption of the name pegrizeprument marks another key milestone for our innovative investigational immunosuppressive therapy as we prepare to move to the next phase of development," said Tunde Otulana, M.D., Chief Medical Officer at Veloxis. "It reinforces our dedication to developing innovative therapies to improve the lives of transplant recipients worldwide."
Novel Mechanism of Action
Pegrizeprument represents a potentially significant advance in transplant immunosuppression with its distinctive mechanism of action. The drug is a pegylated monoclonal monovalent antibody fragment that selectively targets and blocks CD28-mediated effector T-cell costimulation without interfering with CTLA-4, a crucial protein on T cells that naturally regulates immune responses.
This selective approach results in a dual mechanism of action: directly blocking CD28-mediated T cell activation while preserving CTLA-4's natural immunosuppressive functions. This targeted immunomodulation may potentially offer advantages over current immunosuppressive regimens by maintaining efficacy while potentially reducing certain adverse effects associated with broader immunosuppression.
Development History and Future Applications
Originally known as FR104, pegrizeprument was licensed by Veloxis from OSE Immunotherapeutics in April 2021. Under the license agreement, Veloxis secured worldwide rights to develop, manufacture, and commercialize the drug for all transplant indications.
The primary development focus for pegrizeprument is the prevention of acute rejection in kidney transplant recipients, addressing a critical need in transplantation medicine. Organ rejection remains a significant challenge in transplantation, with current immunosuppressive regimens often associated with considerable side effects and variable efficacy profiles.
Beyond kidney transplantation, Veloxis is exploring pegrizeprument's potential applications in other solid organ transplants, potentially expanding its clinical utility across multiple transplant scenarios.
Standardization Benefits for Healthcare
The adoption of a standardized nonproprietary name carries significant practical benefits for healthcare systems. Consistent drug identification helps reduce medication errors, enhances patient safety, and streamlines drug identification for healthcare providers across different settings and geographic regions.
The international recognition aspect of the nonproprietary name is particularly important for transplant medications, as organ transplantation often involves international collaboration and patient mobility. The standardized name ensures clarity regardless of the eventual brand name under which the drug may be marketed in different countries.
About Veloxis Pharmaceuticals
Veloxis Pharmaceuticals, Inc., a subsidiary of Asahi Kasei, is a global specialty pharmaceutical company headquartered in Cary, North Carolina. The company focuses on developing and commercializing medications for transplant patients and those with serious related conditions.
The advancement of pegrizeprument aligns with Veloxis' core mission of improving outcomes for transplant recipients through innovative therapeutic approaches. As the drug progresses through clinical development, it represents a potential addition to the company's portfolio of transplant-focused medications.
The Asahi Kasei Group, Veloxis' parent company, brings substantial resources and global reach to the development program. With more than 49,000 employees worldwide, Asahi Kasei operates across multiple sectors including healthcare, where its operations encompass acute critical care, dialysis, therapeutic apheresis, biotherapeutics manufacturing, pharmaceuticals, and diagnostic reagents.
