Veloxis Doses First Participant in Phase 2 Trial of Pegrizeprument for Kidney Transplant Patients

New Study Looks at an Alternative to Tacrolimus for Long-Term Immunosuppression

Veloxis Pharmaceuticals, part of Asahi Kasei Corporation, has dosed the first participant in its Phase 2 RENGEVITY-201 clinical trial evaluating pegrizeprument, also known as VEL-101, in people receiving kidney transplants.

Pegrizeprument is an investigational maintenance immunosuppressive therapy being developed to help prevent organ rejection after transplantation.

The new trial is an important step in the development program as Veloxis looks at whether pegrizeprument could provide another option for long-term immunosuppression in transplant recipients.

What Is the RENGEVITY-201 Study?

RENGEVITY-201 is a randomized, multicenter, partially blinded, active-control Phase 2 clinical trial.

The study will compare pegrizeprument with tacrolimus, an established immunosuppressive medicine used to help prevent organ rejection after kidney transplantation.

The trial is expected to enroll up to 120 people who are receiving a kidney transplant for the first time.

Participants will receive a combination of rabbit anti-thymocyte globulin, corticosteroids and mycophenolate as part of their maintenance treatment. They will then be randomly assigned in a 1:1:1 ratio to one of three groups.

Two groups will receive different doses of pegrizeprument, while the third group will receive tacrolimus.

Researchers will mainly look at the safety, pharmacokinetics and pharmacodynamics of pegrizeprument. The study will also provide information about how the investigational treatment performs compared with tacrolimus in preventing organ rejection.

Why Kidney Transplant Patients Need Long-Term Treatment

A kidney transplant can restore kidney function, but the treatment does not end after surgery.

Patients need lifelong immunosuppressive therapy to prevent their immune system from attacking the transplanted kidney.

The challenge is that long-term immunosuppression can come with its own problems. Patients may have to follow complicated dosing schedules and can experience treatment-related toxicities and other health complications.

Organ rejection also remains a serious concern because it can affect both the transplanted kidney and the patient's long-term health.

In the United States, an estimated 270,000 people are living with a functioning kidney transplant. This creates a continuing need for treatments that can control the immune response while reducing some of the challenges associated with existing immunosuppressive therapies.

How Pegrizeprument Works

Pegrizeprument is a pegylated monoclonal antibody fragment designed to target a specific part of the immune response.

It binds to and blocks CD28-mediated effector T-cell costimulation. At the same time, it does not block CTLA-4.

This distinction is important because CTLA-4 is a protein on T cells that naturally helps control and reduce immune activity.

Veloxis is developing pegrizeprument around this dual mechanism.

The treatment is expected to directly reduce CD28-mediated T-cell activation while allowing CTLA-4-mediated immunosuppressive activity to continue.

The goal is to control the immune response that can lead to organ rejection without completely shutting down important immune regulation.

Veloxis Moves Pegrizeprument Into Phase 2

Carl Kraus, M.D., chief medical officer of Veloxis, described the move into Phase 2 as an important clinical milestone.

The company said the study could help determine whether pegrizeprument can become a new treatment option in transplantation, an area where there is still room for innovation.

Veloxis is also continuing to develop its broader transplant portfolio, which includes both established treatments and investigational therapies.

Stacy Wheeler, chief executive officer of Veloxis, said the continued development of pegrizeprument reflects the company's focus on addressing unmet needs in transplant medicine.

Pegrizeprument Is Being Studied Across Transplant Types

The kidney transplant study is part of a wider development program for pegrizeprument.

The investigational therapy is being developed for the prevention of acute rejection in solid organ transplant recipients.

The U.S. Food and Drug Administration has already granted pegrizeprument Orphan Drug Designation for additional transplant indications.

In December 2025, the FDA granted Orphan Drug Designation for the prevention of organ rejection in patients receiving a liver transplant.

In March 2026, the FDA granted another Orphan Drug Designation for the prevention of heart allograft rejection in heart transplant recipients.

These designations support the company's plans to investigate pegrizeprument across different types of organ transplantation.

From OSE Immunotherapeutics to Veloxis

Pegrizeprument, also known as VEL-101 and FR104, was licensed by Veloxis from OSE Immunotherapeutics in April 2021.

Under the licensing agreement, Veloxis obtained worldwide rights to develop, manufacture and commercialize pegrizeprument for transplant-related indications.

The company is now advancing the therapy through clinical development as part of its focus on transplant medicine.

What Happens in RENGEVITY-201?

The Phase 2 study will follow kidney transplant recipients receiving maintenance immunosuppression.

Researchers will compare two doses of pegrizeprument with tacrolimus.

The main areas being evaluated include safety, how the drug moves through the body and how it affects biological processes linked to the immune response.

The trial is registered under NCT07290777.

Results from the study will help determine how pegrizeprument performs in kidney transplant recipients and whether its development should move into larger clinical studies.

Veloxis and Its Transplant Focus

Veloxis Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing treatments for transplant recipients and other immunocompromised patients.

The company is headquartered in Cary, North Carolina, and operates as part of Asahi Kasei Corporation.

Its work includes treatments for transplant medicine as well as serious infectious diseases.

The development of pegrizeprument adds another investigational program to its transplant-focused portfolio.

About Asahi Kasei

Asahi Kasei is a diversified global company founded in 1922.

The company has around 50,000 employees worldwide and operates across healthcare, homes and materials.

Its healthcare activities include pharmaceuticals and other products aimed at addressing medical and patient needs.

With pegrizeprument now entering Phase 2 development for kidney transplant recipients, Veloxis is continuing its work on therapies designed to support long-term care for people living with transplanted organs.