Pipeline & Products
A pipeline of breakthrough antiviral therapies for high-risk patients
Overview
Despite the growing demand for preventing and treating infections in immunocompromised patients, few companies focus on this critical area. At Aicuris, we are committed to filling this gap by developing innovative anti-viral solutions tailored to the unique needs of immunocompromised individuals. Our dedication to advancing and delivering therapeutic candidates that make a meaningful impact on patients’ lives drives our pipeline and development decisions.
Pipeline
Pritelivir
A proprietary Phase 3 product candidate with U.S. FDA Breakthrough Therapy designation
Pritelivir
A proprietary Phase 3 product candidate with U.S. FDA Breakthrough Therapy designation
Candidate overview
Pritelivir is an innovative therapeutic candidate designed to inhibit the replication of herpes simplex virus (HSV). As a thiazolylamide-based compound, pritelivir targets both HSV-1 and HSV-2 and has demonstrated efficacy against drug-resistant strains. Standard therapy for HSV infections typically involves antiviral agents such as acyclovir, that inhibit viral DNA replication. However, these treatments require activation by the viral thymidine kinase enzyme, meaning that mutations in this enzyme can lead to drug resistance — an issue that is particularly prevalent in immunocompromised patients.
Pritelivir offers a distinct approach to treating HSV infection by targeting the viral helicase-primase complex, which is essential for HSV DNA synthesis. This unique mechanism allows pritelivir to remain effective against acyclovir-resistant HSV strains, providing a novel solution, particularly for difficult-to-treat cases.
HSV commonly causes recurrent labial and genital herpes infections. While immunocompetent individuals generally manage these infections effectively, immunocompromised patients face more severe complications, including disseminated disease, keratitis, and encephalitis. Given the frequent resistance of HSV to existing drugs, new treatment options are urgently needed.
Clinical trials have shown that pritelivir not only retains activity against resistant HSV but also has favorable tolerability and pharmacokinetic properties. These promising results have led the U.S. FDA to grant pritelivir Breakthrough Therapy designation. Concurrently, the candidate is being evaluated in a pivotal Phase 3 trial for treating acyclovir-resistant HSV infections in immunocompromised patients. Aicuris supports expanded access requests for the treatment of eligible patients outside of the Phase 3 clinical trial.
AIC468
RNA-based therapy to treat BK virus reactivation in kidney transplant patients
RNA-based therapy to treat BK virus reactivation in kidney transplant patients
Candidate overview
AIC468 is a therapeutic candidate designed specifically to treat and reactivation of the BK virus (BKV) in kidney transplant recipients. The antisense oligonucleotide is aimed at disrupting BKV replication directly within infected cells, offering a more targeted and effective solution than existing treatment strategies. This unique approach may reduce the need to alter immunosuppressive therapy, thereby preserving graft function and lowering the risk of rejection.
About
BK virus
BK virus (BKV), a common polyomavirus, infects most people in early childhood, usually without symptoms. In immunocompromised individuals, such as organ transplant recipients, BKV can reactivate and pose severe health risks. BKV reactivation is a significant risk for kidney transplant patients; if it progresses to BKV-associated nephropathy, it can result in graft dysfunction and, ultimately, graft loss. Currently, no approved antiviral treatments exist for BKV infections. The standard of care approach involves reducing immunosuppressive therapy, which increases the risk of graft rejection and transplant failure.
Preclinical studies have shown that AIC468 has favorable pharmacokinetics and has substantially inhibited BKV replication, demonstrating its potential as a breakthrough treatment for BKV management in transplant patients. A first-in-human clinical trial was initiated in Q4 2024 to evaluate the safety, tolerability, and pharmacokinetics of AIC468 in healthy volunteers. A topline data readout is expected in 2025.
Drug Discovery
Aicuris is dedicated to advancing therapeutic innovations for immunocompromised patients.
Aicuris is dedicated to advancing therapeutic innovations for immunocompromised patients.
We leverage our longstanding experience in discovery and development of direct acting antivirals towards areas of high medical need. In particular, we actively seek to discover a systemic adenovirus treatment for immunocompromised patients having undergone solid organ or stem cell transplantation. In these patients, many of which are children, adenovirus is a life-threatening disease for which very few therapeutic options exist. There is an urgent need for a novel, orally available, direct acting antiviral to address adenovirus infections.
About Candidate
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Letermovir
Transforming transplantation medicine with an innovative antiviral solution