The medicine Pritelivir is to enter Phase III clinical trials for the treatment of immunocompromised patients who have acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections.
Immunocompromised patients with HSV often have a chronic form of the virus which is resistant to any anti-viral medication, including acyclovir. Following Phase I and II trials of Pritelivir, AiCuris, a leading company in the discovery and development of drugs against infectious diseases, has received approval from the German “Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)” to initiate a Compassionate Use Programme for Pritelivir for the treatment of immunocompromised patients who have acyclovir-resistant mucocutaneous herpes simplex virus infections, as well as foscarnet resistance or intolerance.
Compassionate Use Programme
The Compassionate Use Programme (CUP) may help provide access to Pritelivir for immunocompromised patients. Compassionate use is a treatment option that allows the use of an unauthorised medicine to treat patients who have a disease which cannot be treated with any currently authorised medicine, and who cannot enter clinical trials.
These programmes are only put in place if there is sufficient evidence of the effectiveness and safety of the drug and if the medicine is expected to help patients with life-threatening, long-lasting, or seriously debilitating illnesses.
Dr Holger Zimmermann, CEO of AiCuris, said: “Especially in immunocompromised patients, HSV can lead to serious complications. We are very happy that with this program we can give seriously ill patients with no further treatment options access to Pritelivir, a novel and resistance breaking therapeutic agent, and thus again hope.
“At the same time, the data collected in this programme will help to bring the drug to patients as quickly as possible and support the planned approval of Pritelivir.”
AiCuris was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for Pritelivir in June.