CARY, N.C. -- September 01, 2026 -- Veloxis Pharmaceuticals dosed the first participant on Aug. 31, 2026, in its Phase 2 RENGEVITY-201 trial testing pegrizeprument, an investigational immunosuppressive drug, against tacrolimus in kidney transplant recipients. The Cary, North Carolina-based company, a unit of Asahi Kasei Corporation, will enroll up to 120 de novo kidney transplant patients across multiple sites in the randomized, partially blinded study registered as NCT07290777. Patients will receive one of two pegrizeprument doses or tacrolimus, each layered on top of rATG, corticosteroids and mycophenolate maintenance therapy.
Trial randomizes patients 1:1:1 across three treatment arms
RENGEVITY-201 assigns participants in equal proportions to two pegrizeprument dose groups or the tacrolimus control arm. The study's stated primary objectives cover safety, pharmacokinetics and pharmacodynamics of pegrizeprument in the de novo transplant setting. Veloxis obtained worldwide development, manufacturing and commercialization rights to the compound for all transplant indications through an April 2021 license agreement with OSE Immunotherapeutics.
Compound blocks CD28 signaling while leaving CTLA-4 pathway intact
Pegrizeprument, also known as VEL-101 and FR104, is a pegylated monoclonal antibody fragment engineered to block CD28-mediated effector T-cell costimulation without interfering with CTLA-4, a protein that helps regulate immune responses. Veloxis describes the drug as carrying a dual mechanism: direct blockade of CD28-driven T-cell activation paired with preserved CTLA-4 immunosuppressive function. The company is developing the agent for prevention of acute rejection across solid organ transplant types.
FDA granted orphan status for liver and heart transplant applications
The FDA granted pegrizeprument Orphan Drug Designation for prevention of organ rejection in liver transplant recipients in December 2025, followed by a second designation in March 2026 covering prophylaxis of heart allograft rejection. Neither designation currently applies to the kidney transplant indication under study in RENGEVITY-201.
CMO says trial narrows gap toward new maintenance therapy option
Carl Kraus, Chief Medical Officer of Veloxis, said advancing pegrizeprument into Phase 2 marks a milestone that moves the company closer to offering a new therapy in a field where meaningful innovation opportunities remain limited. An estimated 270,000 people in the United States currently live with a functioning kidney transplant, according to Veloxis, and require lifelong immunosuppression that often carries complex dosing regimens and toxic side effects. The company cited persistent complications from immunosuppression and allograft rejection as ongoing threats to graft and patient survival despite existing post-transplant care protocols.