Veloxis Doses First Patient in Phase 2 RENGEVITY-201 Trial of Pegrizeprument for Kidney Transplant Rejection Prevention
核心洞察
Veloxis Pharmaceuticals (搜索) has dosed the first participant in its Phase 2 RENGEVITY-201 trial (NCT07290777) evaluating pegrizeprument (搜索) (VEL-101) in kidney transplant recipients.
The randomized, multicenter, partially blinded, active-control study will compare pegrizeprument (搜索) against tacrolimus in up to 120 de novo kidney transplant recipients.
Pegrizeprument (搜索) is a pegylated monoclonal antibody fragment that blocks CD28 (搜索)-mediated effector-T cell costimulation while preserving CTLA-4 (搜索)-mediated immunosuppression.
Veloxis Pharmaceuticals (搜索), Inc., a global specialty pharmaceutical company and part of Asahi Kasei Corporation (搜索), announced that the first participant has been dosed in its Phase 2 clinical trial (NCT07290777) of pegrizeprument (搜索), a novel investigational maintenance immunosuppressive agent being studied for the prevention of organ rejection (搜索) in kidney transplant recipients.
"Advancing pegrizeprument (搜索) into a Phase 2 study is an important clinical milestone for Veloxis and brings us one step closer to offering a potential new innovative therapy in a field where opportunities for meaningful innovation remain significant. We're grateful to the participants, investigators, and study teams making this trial possible," said Carl Kraus, MD, Chief Medical Officer of Veloxis.
Study Design and Objectives
The Phase 2 study, RENGEVITY-201, is a randomized, multicenter, partially blinded, active control trial evaluating the safety and efficacy of pegrizeprument (搜索) compared with tacrolimus in the prevention of organ rejection (搜索) in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG with corticosteroids and mycophenolate as maintenance therapy and will be randomized 1:1:1 to receive either pegrizeprument (one of two doses) or tacrolimus. The primary objectives of the study will evaluate the safety, pharmacokinetics, and pharmacodynamics of pegrizeprument.
Mechanism of Action
Pegrizeprument (搜索) is a pegylated monoclonal antibody fragment that binds to and blocks CD28 (搜索)-mediated effector-T cell costimulation, without blocking CTLA-4 (搜索), an important protein found on T cells that naturally helps keep the body's immune responses in check. Pegrizeprument is therefore expected to have a dual mechanism of action: in a direct manner, it blocks CD28-mediated T cell activation, and indirectly, it allows for CTLA-4-mediated immunosuppressive functions. Pegrizeprument is currently being developed for the prevention of acute rejection in solid organ transplant recipients.
Unmet Need in Transplantation
Kidney transplant recipients require life-long immunosuppression, often associated with complex dosing regimens and comorbid toxicities. Despite advancements in post-transplant clinical care, complications of immunosuppression and allograft rejection may negatively impact graft and patient survival. With an estimated 270,000 people living with a functioning kidney transplant in the United States, there remains a significant unmet need for new therapies that address these complications while maintaining adequate immunosuppression.
"Our transplant franchise is built on a commitment to advancing care for transplant recipients through both established and investigational therapies," said Stacy Wheeler, Chief Executive Officer of Veloxis. "The continued development of pegrizeprument (搜索), together with ongoing investments in transplant-focused innovation, reflects our dedication to addressing important unmet needs and expanding future therapeutic possibilities for the transplant community."
Regulatory Milestones and Development History
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to pegrizeprument (搜索) for the prevention of organ rejection (搜索) in patients receiving a liver transplant in December 2025 and for the prophylaxis of heart allograft rejection in patients receiving a heart transplant in March 2026.
Pegrizeprument (搜索), also known as VEL-101 and FR104, was licensed by Veloxis Pharmaceuticals (搜索), Inc. from OSE Immunotherapeutics in April 2021. As part of the license agreement, Veloxis Pharmaceuticals, Inc. obtained worldwide rights to develop, manufacture, and commercialize pegrizeprument for all transplant indications.