AiCuris Anti-infective Cures has launched a first-in-human Phase I trial of AIC468, an antisense oligonucleotide designed to combat BK virus (BKV) infections in kidney transplant (KT) recipients.
The study will evaluate the tolerability, safety and pharmacokinetics of AIC468 in healthy participants.
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The double-blind, randomised, placebo-controlled trial in 72 healthy volunteers aged 18-64 will be conducted in Germany.
It includes both single and multiple ascending doses of the therapy. Topline data information from the single-ascending dose part is anticipated in 2025.
AiCuris CEO Larry Edwards said: “This trial marks another significant milestone in our mission to develop innovative therapies for patients with weakened immune systems, who are particularly vulnerable to serious viral infections like BK virus infections.
“The initiation of this trial demonstrates the strength and diversity of our pipeline as we continue to advance cutting-edge solutions for high-risk patient populations. With multiple programmes now in the clinic, we are confident that our approach can make a meaningful impact on the lives of immunocompromised patients.”
BKV is a widespread polyomavirus that most people contract in early childhood, usually without symptoms.
However, in individuals with compromised immune systems, such as organ transplant recipients, BKV reactivation may occur and lead to severe health complications.
For KT patients, this reactivation may develop BK virus-associated nephropathy (BKVAN), which affects up to 10% of recipients and can result in graft loss.
The current approach to managing BKV reactivation in KT patients involves reducing immunosuppressive therapy, which increases graft rejection risk.
Based in Germany, AiCuris specialises in developing precise therapies for immunocompromised individuals to treat infections.
The company’s lead candidate, PREVYMIS, used to prevent cytomegalovirus (CMV) in a specific group of transplant recipients, is marketed by its partner MSD.
