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 (Link to Trial). 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.
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.