Veloxis Pharmaceuticals Doses First Patient in RENGEVITY-201 Phase 2 Trial of Pegrizeprument for the Prevention of Organ Rejection in Kidney Transplant Recipients

• First participant dosed in Phase 2 RENGEVITY-201 study evaluating pegrizeprument (VEL-101) in kidney transplant recipients
• Pegrizeprument is being developed as a novel maintenance immunosuppressive therapy for the prevention of organ rejection in transplant recipients
• This clinical milestone reinforces Veloxis' leadership and long-standing commitment to innovation in transplantation

CARY, N.C., Aug. 31, 2026 /PRNewswire/ -- Veloxis Pharmaceuticals, Inc. (Veloxis), 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 [NCT07290777] 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.

About pegrizeprument
Pegrizeprument is a pegylated monoclonal antibody fragment that binds to and blocks CD28‑mediated effector-T cell costimulation, without blocking CTLA-4, 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 where 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.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to pegrizeprument for the prevention of organ rejection 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, also known as VEL-101 and FR104, was licensed by Veloxis Pharmaceuticals, 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.

About Veloxis Pharmaceuticals
Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a global specialty pharmaceutical company committed to improving the lives of transplant and other immunocompromised patients. Headquartered in Cary, North Carolina, USA, Veloxis is focused on the global development and commercialization of treatments that address areas of unmet needs in transplant medicine and serious infectious diseases. For further information, please visit Veloxis.com.

About Asahi Kasei
Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world's challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit https://www.asahi-kasei.com/.

Contact:

Veloxis Pharmaceuticals 
Anna Michaels
Director, Corporate Communications
[email protected]

Media 
David Rosen
Argot Partners
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646-461-6387

SOURCE Veloxis Pharmaceuticals