Veloxis Pharmaceuticals, Inc., a global specialty pharmaceutical company part of Asahi Kasei Corporation, today announced that the first participant has been dosed in its Phase 2 clinical trial of pegrizeprument, a novel investigational maintenance immunosuppressive agent being studied for prevention of organ rejection in kidney transplant recipients.

“Advancing pegrizeprument 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.

The Phase 2 study, RENGEVITY-201, is a randomized, multicenter, partially blinded, active control trial evaluating the safety and efficacy of pegrizeprument compared with tacrolimus in the prevention of organ rejection 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.

“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, 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.”

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.

For more information, visit https://www.veloxis.com/.