COPENHAGEN, Denmark — May 28, 2026
Synklino A/S announced that the first patient has been dosed in a first-in-human Phase 1 clinical trial evaluating SYN002 for the prevention of cytomegalovirus (CMV) reactivation in kidney transplant recipients. The study marks a major clinical milestone for the company’s first-in-class ex vivo transplant therapy platform designed to improve transplant outcomes by targeting latent CMV infection before organ transplantation.
SYN002 Targets Hidden CMV Reservoirs in Donor Kidneys
CMV remains one of the most significant infectious complications following kidney transplantation. Approximately 60–70% of donor organs are CMV-positive, placing transplant recipients at increased risk of viral reactivation, hospitalization, graft complications, and long-term morbidity despite standard antiviral prophylaxis. Existing antiviral therapies primarily target active viral replication but have limited ability to eliminate latent CMV reservoirs embedded within donor organs.
SYN002 was developed to address this critical gap through a novel mechanism targeting CMV-encoded membrane receptors expressed on both active and latent infected cells. Unlike conventional systemic antiviral approaches, SYN002 is administered directly to donor kidneys ex vivo during organ perfusion prior to transplantation, allowing targeted treatment of the organ without exposing recipients to systemic drug toxicity.
According to the company, preclinical human kidney studies published in the American Journal of Transplantation demonstrated that SYN002 achieved a greater than 90% reduction in CMV reactivation from latency, providing the scientific foundation for advancing the therapy into clinical testing.
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Phase 1 Trial Underway at Leading Transplant Center
The investigator-sponsored Phase 1 dose-escalation study is currently underway at the University Health Network Ajmera Transplant Centre in Toronto, one of the world’s leading transplant institutions performing more than 600 solid organ transplants annually.
The study is being led by Atul Humar, an internationally recognized expert in transplant infectious diseases and CMV management. The trial will evaluate the safety and tolerability of SYN002 across four cohorts of recipients receiving CMV-positive donor kidneys, while also exploring early efficacy signals related to viral reactivation prevention over a six-month follow-up period.
Initial safety findings from the first patient cohort are expected during the second half of 2026, with final study readout anticipated in 2027.
Dr. Ian McGowan, Chief Medical Officer of Synklino, stated that the initiation of human clinical testing represents a key development milestone for the company and could help validate the translational potential of the strong preclinical data generated in donor kidney models.
Novel Ex Vivo Strategy Could Transform Transplant Infection Prevention
Researchers and transplant specialists continue to search for improved methods to prevent CMV complications after transplantation, as current prophylactic strategies still leave nearly 30% of recipients vulnerable to viral reactivation. Persistent CMV infection can negatively affect graft survival and significantly increase healthcare burden following transplant procedures.
Synklino’s organ-directed ex vivo therapy approach represents a differentiated strategy within transplant medicine by treating the donor organ directly before implantation. If successful, the platform could potentially expand beyond CMV prevention into additional infectious and immune-mediated transplant complications.
The Phase 1 trial further strengthens Synklino’s position in the emerging field of precision transplant therapeutics, where innovative ex vivo interventions are gaining growing attention as a way to improve long-term transplant outcomes and reduce post-operative complications.
Source: Synklino press release
