AiCuris Starts Phase 1 Trial With Antiviral AIC468 for BK Virus in Kidney Transplant Patients

WUPPERTAL, Germany I October 31, 2024 I AiCuris Anti-infective Cures AG has officially announced the beginning of its Phase 1, first-in-human study of AIC468, a new antisense oligonucleotide, which is an antiviral agent aimed at treating BK virus (BKV) infections in kidney transplant (KT) recipients. BKV reactivation in these patients represents a significant unmet medical requirement due to the lack of approved medications. The Phase 1 study (2023-510074-13-00) will assess the safety, tolerability, and pharmacokinetics of AIC468 in healthy participants.

“BK virus infections continue to be a critical concern for transplant recipients, often resulting in graft loss and other severe complications,” stated Cynthia Wat, MD, CMO of AiCuris. “Moving AIC468 into clinical trials is a vital step towards offering a targeted treatment that directly inhibits BK virus replication, addressing this pressing need. Our team is dedicated to enhancing patient outcomes for those facing the difficulties of post-transplant viral infections.”

“This trial is a noteworthy achievement in our objective to develop innovative therapies for patients with compromised immune systems, who are particularly vulnerable to serious viral infections like BK virus,” commented Larry Edwards, CEO of AiCuris. “Initiating this trial highlights the robustness and variety of our pipeline as we progress with advanced solutions for high-risk patient groups. With several programs now in clinical stages, we believe our strategy can significantly improve the lives of immunocompromised patients.”

The first-in-human trial, which is randomized, double-blind, and placebo-controlled, will evaluate the safety, tolerability, and pharmacokinetics of AIC468 in 72 healthy volunteers. Taking place in Germany, the trial involves both single and multiple ascending doses of AIC468. Results from the single ascending dose portion of the study are anticipated in 2025.

BK virus (BKV) is a common polyomavirus that infects most individuals in early childhood, usually without symptoms. However, in immunocompromised individuals, such as organ transplant recipients, BKV can reactivate and cause severe health problems. In kidney transplant patients, BKV reactivation can lead to BK virus-associated nephropathy (BKVAN), which affects up to 10% of recipients and may result in graft loss. Current management strategies involve reducing immunosuppressive therapy, which increases the risk of graft rejection. Despite its prevalence, no antiviral treatment specifically for BKV has been approved.

AiCuris is dedicated to addressing the needs of the growing number of immunocompromised individuals who require specialized therapies to effectively treat infections. Their flagship product, PREVYMIS®, marketed by their partner MSD, prevents CMV in a specific group of transplant recipients. Their pivotal Phase 3 candidate, pritelivir, is aimed at treating recurrent and resistant HSV infections in a wide population of patients with weakened immune systems. For immunocompromised people, what might be a manageable infection for others can be life-threatening. AiCuris, with its expertise and expanding pipeline, is committed to providing therapeutic solutions now and in the future.