Pritelivir, a proprietary phase 3 product candidate with FDA breakthrough designation
Pritelivir is an innovative, therapeutic candidate inhibiting HSV replication, currently being evaluated in a pivotal phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. In immunocompetent individual, HSV causes highly recurrent labial and genital herpes infections. In immunocompromised patients, HSV symptoms are more severe and include disseminated disease, keratitis and encephalitis. Resistances to marketed drugs are often described. Derived from a novel chemical class (thiazolylamides), Pritelivir is active against both types of herpes simplex virus (HSV-1 and HSV-2). In previous clinical trials, Pritelivir retained activity against viruses resistant to marketed drugs and showed favorable tolerability and pharmacologic properties. Based on these results, Pritelivir was granted Breakthrough Therapy Designation by the US FDA.
Early Access to Pritelivir oral tablets for immunocompromised patients with resistant HSV infections
AiCuris supports expanded access requests for the treatment of eligible patients outside of the Ph3 clinical trial and collaborate with myTomorrows to facilitate early access to Pritelivir for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. EAPs (also known as “Expanded Access Program” or “Named-Patient Use”) offer an ethical, compliant, and controlled way of providing treatment with a medicine currently not licensed in a patient’s country of residence. Eligible patients for an EAP are in high medical need, cannot participate in a Clinical Trial, and have exhausted all registered treatment options. More information can be requested here
To get access, patients need to consult with their treating physician to explore all treatment options. If the physician agrees to a treatment with Pritelivir oral tablets and to oversee the patient's treatment, the physician is to contact the myTomorrows medical team for more information on this EAP. When providing medical information about the patient, please note that only anonymized data shall be included in any patient information. Due to EU data protection law this shall not be accompanied by personal data.
RNA-based therapy to prevent BK viral reactivation in kidney transplant patients to enter clinical testing next year
AIC468, a RNA-based program to prevent BKV infections and re-activation in patients with transplanted kidneys, is an antisense oligonucleotide designed to target a mRNA encoding a protein critical for viral replication.
BKV-positive individuals might develop BKV-associated nephropathy and lose their transplant. As there are no approved antiviral drugs for BKV infections, the current treatment for transplanted patients is to reduce the amount of immunosuppression therapy, which in turn increases the likelihood of transplant rejection and loss. AIC468 directly targets viral replication within infected cells, thus potentially overcomes limitations of other approaches in development. In preclinical studies, AIC468 has demonstrated favorable pharmacokinetics and significant inhibition of BKV replication. Start of the first in human trial is planned for 2024.
Developing innovative treatments for infections with Adenovirus
Preclinical programs are designed to combat human ADV infections, including systemic infections in pediatric transplant patients as well as ocular infections, specifically epidemic keratoconjunctivitis (EKC). Despite the high incidence, severity, and viral cause of ADV eye infections, there are currently no approved treatments addressing the root cause of these conditions. In response to this unmet medical need, we are advancing several programs.
Marketed product that disrupted transplantation medicinen
PREVYMIS®, licensed to MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (NYSE: MRK)), is a first-in-class antiviral agent that was approved by the FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT. PREVYMIS® is marketed in this indication in more than 60 countries outside the US, including in the EU, Canada, Japan and China with increasing annual revenues.
Just recently, the drug was approved by the US FDA for its second indication - the prophylaxis of CMV disease after kidney transplantation in donor CMV-seropositive/recipient CMV-seronegative patients.