Synklino announces first patient dosed in Phase 1 trial of SYN002 for CMV prevention in kidney transplantation

• Study to evaluate the safety and exploratory efficacy of SYN002 in recipients of human cytomegalovirus (CMV) positive donor kidneys, and to monitor for viral reactivation over the six months following transplantation 
• Investigator-sponsored Phase 1 trial underway at the Ajmera Transplant Centre, University Health Network (UHN), Toronto, a world-renowned transplant center, conducted by Professor Atul Humar
• Builds on preclinical human kidney proof-of-concept data published in the American Journal of Transplantation demonstrating that SYN002 is associated with >90% reduction in CMV reactivation from latency
  

COPENHAGEN, Denmark, May 28, 2026 (GLOBE NEWSWIRE) -- Synklino A/S, a clinical-stage biotechnology company developing a first-in-class, ex vivo therapy to transform kidney transplantation outcomes through better CMV prevention, today announces the first patient has been dosed in a first-in-human Phase 1 clinical trial of SYN002 for the prevention of cytomegalovirus (CMV) reactivation in kidney transplant recipients.

Approximately 60–70% of donor organs are CMV-positive, creating significant post-transplant health risks associated with CMV transmission and reactivation. Current standard-of-care relies on antiviral prophylaxis, which targets only lytic infection. Despite prophylactic treatment, CMV reactivation is observed in approximately 30% of transplant recipients, potentially leading to poorer transplant outcomes, rehospitalization, and increased morbidity and mortality.

SYN002 targets CMV-encoded membrane receptor expressed on both lytic and latently infected cells and is designed to selectively target CMV-infected cells, thereby reducing the latent reservoir that current antivirals cannot reach. SYN002 is an investigational drug that is administered to donated organs ex vivo during organ perfusion, prior to transplantation, enabling direct treatment of the donor organ without exposing the transplant recipient to systemic therapy.

The Phase 1 dose-escalation study will evaluate the safety and tolerability of SYN002 across four cohorts of donor kidney recipients, with exploratory efficacy as a secondary endpoint. The study will enroll CMV-positive and CMV-negative transplant recipients of CMV-positive donor kidneys. Participants will be followed for six months post-transplant, enabling the study to ascertain whether SYN002 is associated with a reduced rate of viral reactivation compared to historical rates. Initial safety findings from the first cohort are anticipated in the second half of 2026 with final readout expected in 2027.

Ian McGowan, MD PhD, Chief Medical Officer, Synklino, added: “The recent publication of our data in the American Journal of Transplantation established preclinical proof-of-concept for SYN002 in human kidneys. Initiating this Phase 1 study allows us to begin evaluating whether those findings translate into transplant patients. This represents a key milestone in the development of SYN002 for CMV prevention and our broader goal of improving transplant outcomes for patients who remain at risk despite current standard-of-care prophylaxis.”

The study is currently underway at the UHN’s Ajmera Transplant Centre in Toronto, home to Canada's largest transplant program and one of the world's leading transplant centers, performing more than 600 solid organ transplants each year. Leading the study is Professor Atul Humar of the Department of Medicine at the UHN, Toronto, Canada who is internationally recognized for his work in transplant infectious diseases, specializing in CMV prevention and treatment.

Professor Atul Humar, Principal Investigator of the study, commented: “Despite the advances in antiviral prophylaxis for the prevention of CMV disease after kidney transplantation, we still see patients who become viremic after their transplant and some of them develop overt CMV disease. SYN002 represents a novel approach to CMV prevention in this patient population, and the start of dosing is an important step forward as we begin to evaluate SYN002 in the clinic”.

The Phase 1 trial builds on preclinical proof-of-concept data published in the American Journal of Transplantation, generated in collaboration with Professor Michael Nicholson’s group at the University of Cambridge and Addenbrooke’s Hospital. The study demonstrated that SYN002 was associated with greater than 90% reduction in CMV reactivation from latency in human donor kidneys treated ex vivo, providing the foundational evidence supporting evaluation of SYN002 in transplant recipients.

For further information please contact:

Synklino A/S
Thomas Kledal, CEO
info@synklino.com
Tel: +45 2012 1656

Optimum Strategic Communications
Mary Clark | Isabelle Abdou | Vareen Outhonesack | Katherine Bliss
Email: Synklino@optimumcomms.com
Tel: +44 20 3922 0900

About Synklino 

Synklino is a clinical-stage biotechnology company developing a first-in-class ex vivo therapy to improve kidney transplantation outcomes through better cytomegalovirus (CMV) prevention. CMV is present in 60–70% of donor organs and remains a major cause of post-transplant complications, associated with delayed graft function and reduced graft durability. Synklino's approach is designed to significantly reduce both latent and active CMV directly in the donor organ before transplantation, aiming to reduce the need for prolonged antiviral prophylaxis, lowering the incidence of CMV viremia and rehospitalization, and improving overall transplant outcomes.

Synklino's lead program, SYN002, is administered ex vivo during kidney perfusion, enabling direct treatment of the donor organ for CMV without exposing the transplant recipient to systemic therapy. SYN002 is in Phase 1 clinical development at the Ajmera Transplant Centre, University Health Network, Toronto – one of the world's leading transplant centers – led by Professor Atul Humar. The program is supported by peer-reviewed, preclinical proof-of-concept data in human donor kidneys, generated in collaboration with Professor Michael Nicholson at the University of Cambridge and Addenbrooke’s Hospital and published in the American Journal of Transplantation. Synklino retains broad intellectual property rights to SYN002 and its ex vivo use in organ perfusion.

Headquartered in Copenhagen, Denmark, Synklino is initially focused on kidney transplantation, with potential to expand into other solid organ transplants. For more information, visit www.synklino.com.

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