Asahi Kasei Therapeutics Announces First Patient Dosed in Phase 2a Trial of AIC468 for BK Virus Infection in Kidney Transplant Recipients

TOKYO--(BUSINESS WIRE)--Asahi Kasei Therapeutics, Inc., the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, today 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.

About BKV

BKV is a ubiquitous human polyomavirus that is typically acquired in early childhood and persists lifelong without symptoms in more than 90% of the adult population. In immunocompromised individuals, such as organ transplant recipients, BKV can reactivate, leading to serious health issues. In kidney transplant patients, BKV reactivation in the transplanted kidney can cause BK virus-associated nephropathy (BKVAN), affecting up to 10% of recipients and potentially resulting in graft loss. Current management involves reducing immunosuppressive therapy, which increases the risk of graft rejection. Despite its prevalence, there is no approved antiviral treatment specifically for BKV.

About AIC468

AIC468 is an antiviral antisense oligonucleotide (ASO) in clinical development for the treatment of BK virus replication in kidney transplant recipients. The candidate inhibits viral replication in infected cells by modulating splicing of the BKV early coding pre‑mRNA, thereby preventing formation of the mRNA encoding the essential BKV master regulator protein, large T antigen. This innovative approach has already demonstrated potent antiviral activity along with a favorable pharmacokinetic and safety profile in preclinical studies and in a Phase 1 clinical trial in healthy volunteers.

About Asahi Kasei Therapeutics

Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Tokyo-based Asahi Kasei. We are identifying, developing, and commercializing innovative medicines for diseases with significant unmet medical needs. Drawing upon our strong heritage of scientific innovation, we are expanding therapeutic options and helping to positively impact health in immunology, nephrology, transplantation, and infectious diseases. For more information, visit: www.aktx.com/.

About Asahi Kasei

Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world’s challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit https://www.asahi-kasei.com/.