Pritelivir is an innovative, therapeutic candidate inhibiting HSV replication. It is,currently being evaluated in a pivotal Phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients (Link to Trial).
HSV causes recurrent labial and genital herpes infections. While these infections are easily managed in immunocompetent individuals, HSV symptoms in immunocompromised patients are more severe and include disseminated disease, keratitis and encephalitis. Resistances to existing marketed drugs is common and novel solutions are urgently needed.
Derived from a novel chemical class (thiazolylamides), pritelivir is effective against both HSV-1 and HSV-2. In previous clinical trials, pritelivir demonstrated activity against drug-resistant viruses 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 Phase 3 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 approved 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 needs to contact the myTomorrows medical team for more information on the 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.