Asahi Kasei Therapeutics doses first patient in Phase 2a trial of AIC468 for BK virus

Trial milestone

Asahi Kasei Therapeutics has dosed the first patient in a randomized Phase 2a clinical trial (NCT07503561) evaluating AIC468 in adult kidney transplant recipients with BK virus infection. The investigational program was developed by Aicuris Anti‑infective Cures AG, which is now part of Asahi Kasei Therapeutics.

Study design and objectives

The double‑blind, placebo‑controlled Phase 2a is part of a Phase 2/3 program designed to evaluate safety, tolerability, and the pharmacokinetic profile of AIC468 across multiple dose levels in patients after kidney transplantation. Trial outcomes will be assessed by frequency and severity of treatment‑emergent adverse events (TEAEs).

Candidate profile and prior data

AIC468 is an antiviral antisense oligonucleotide that inhibits BK virus replication by modulating splicing of the BKV early coding pre‑mRNA, preventing formation of the mRNA that encodes the essential large T antigen. Progression into Phase 2a is supported by favorable Phase 1 safety, tolerability and pharmacokinetic data from healthy volunteers, alongside preclinical antiviral activity and safety findings.

Clinical context

BK virus is ubiquitous, typically acquired in early childhood and persisting lifelong in more than 90% of adults. In immunocompromised patients such as kidney transplant recipients, reactivation can cause BK virus‑associated nephropathy, affecting up to 10% of recipients and potentially resulting in graft loss. Current management relies on reducing immunosuppression, which raises the risk of graft rejection, and no approved antiviral therapy for BKV exists.