Asahi Kasei Therapeutics, Inc., the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, recently announced that the first patient has been dosed in a randomized Phase 2a clinical trial (NCT07503561) evaluating AIC468, a novel antiviral antisense oligonucleotide (ASO), in adult kidney transplant recipients with BK virus (BKV) infection. The investigational program was developed by Aicuris Anti-infective Cures AG (Aicuris), which is now part of Asahi Kasei Therapeutics.
“BK virus reactivation, while relatively harmless in immunocompetent people, remains a major complication for kidney transplant recipients, as reactivation of the virus can lead to graft dysfunction and BK nephropathy,” said Carl Kraus, MD, Chief Medical Officer of Asahi Kasei Therapeutics. “For transplant patients and their families, this means a high risk of losing the transplanted kidney. Following encouraging Phase 1 data in healthy volunteers, dosing the first patient in this study represents an important step toward developing a targeted antiviral therapy for a community with no approved treatment options. Our goal is to help protect transplanted organs and improve long-term outcomes for these patients.”
The randomized, double-blind, placebo-controlled Phase 2a trial is part of a Phase 2/3 program designed to evaluate safety, tolerability, and pharmacokinetic profile in adult patients with BKV infection after kidney transplantation across multiple dose levels as assessed by frequency and severity of treatment-emergent adverse events (TEAEs). Progression into Phase 2a is supported by favorable Phase 1 safety, tolerability, and pharmacokinetic data.
