COPENHAGEN (July 7th, 2025) – Synklino A/S, a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention, today announced the submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its first-in-human clinical trial of SYN002.
The submission marks a significant milestone for Synklino, bringing its lead drug candidate into clinical development with the commencement of first-in-human study. The planned clinical trial is a Phase 1 study evaluating the safety and pharmacokinetics of SYN002 for ex vivo treatment of CMV in kidneys from CMV-positive donors.
The Phase 1 study will be conducted at centers in the UK led by Professor Michael Nicholson at the University of Cambridge. “We are excited to be working with Professor Michael Nicholson and our other clinical partners across the UK,” said Ian McGowan, CMO of Synklino. “We look forward to bringing SYN002 one step closer to the patients who need better options for CMV prevention”
To support the initiation and conduct of the study Synklino is actively advancing its financing strategy. The company is engaged in discussions with a syndicate of investors and continues to pursue both non-dilutive and equity-based funding to ensure execution of the clinical program. The Phase 1 study is expected to commence once financing to advance the trial has been secured.
Synklino has had a late breaking abstract accepted for oral presentation at the World Transplant Congress which will be held in San Francisco, USA in the period 2-6 August 2025. The presentation will focus on preclinical data from human kidney ex vivo perfusion studies conducted in collaboration with the University of Cambridge, UK.
“Reactivation of CMV after transplantation remains an important challenge in transplantation medicine,” said Thomas Kledal, CEO at Synklino. “Our pre-clinical ex vivo data are very exciting as the experiments closely resemble the approach we will use in our Phase 1 study, which will be the first CMV depletion therapy entering clinical development.”
Synklino
Synklino is a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention. We aim to build a pipeline by harnessing our proprietary target-identification platform to tailor novel antiviral drug candidates. Our first-in-class breakthrough treatment, SYN002, is a therapeutic fusion protein designed to revolutionize the standard of care prophylaxis for CMV by eliminating both active and latent CMV-infected cells in donated organs through ex vivo organ perfusion, offering a preventative solution for immunocompromised transplant recipients.
Background
Cytomegalovirus (CMV) is the main agent involved in infectious complications following transplant surgery, and a major risk for morbidity and increased hospital readmissions. CMV is a chronic viral infection found in more than 60% of humans worldwide. A healthy individual’s immune system confines the virus to an inactive but persistent state; however, in transplant patients with suppressed immune systems, CMV emerges from latency and significantly impacts morbidity and mortality. CMV increases transplant costs by up to 50% due to long-term hospitalizations and requires difficult courses of treatment. CMV-infected organs constitute a key risk for CMV infection and complications in all transplant recipients at the time of transplantation, regardless of the recipient’s CMV status. No currently marketed or pipeline drugs can cure CMV, and current drugs can be associated with the risk of developing resistance to CMV-therapies.
SYN002 is a therapeutic fusion protein, uniquely targeting both latent and lytic CMV- infected cells. SYN002 is expected to be highly efficacious and potent compared to standard of care antiviral therapeutics which only target active (lytic) infection. Given the compound’s unique mechanism of action, SYN002 has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients who would otherwise receive a CMV-infected organ. In preclinical studies SYN002 has been shown to be fast-acting with full efficacy anticipated within the few hours that the organ is treated ex vivo (outside the body).
Ex vivo organ perfusion is the treatment of an organ after it has been removed from the donor, and prior to transplantation. Ex vivo organ care has evolved from storage on ice into dynamic reconditioning using machine perfusion. Continuous flushing of donor organs with fluids during machine perfusion allows enhanced preservation with assessment of critical organ function parameters. Organ perfusion enables improvements inf organ function by supplementing blood products or solutions that contain important nutrients, cells, and therapeutics, such as SYN002. Ex vivo machine perfusion increases the number of organs available for transplantation, ultimately improving the chance for a life-saving outcome for patients with end stage renal failure.
For additional information, please contact:
Synklino
Thomas Kledal, CEO
+45 2012 1656
tnk@synklino.com