Posted by Michael Wonder on 02 Aug 2017
AiCuris granted fast track designation by U.S. FDA for oral pritelivir for treatment of HSV infections in immunocompromised adults
1 August 2017 - AiCuris today announced that the Company has been granted fast track designation by the U.S. FDA for oral pritelivir, AiCuris’ lead candidate for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus infections in immunocompromised adults.
Oral pritelivir, a small molecule helicase-primase inhibitor with a novel mode of action, is currently in a clinical phase 2 study, called PRIOH-1, in the U.S. to evaluate the product candidate’s efficacy and safety compared to i.v. foscarnet, a virostatic agent which is used mainly for the treatment of herpes viruses resistant to other antiviral drugs. In a prior phase 2 study, oral pritelivir showed to significantly improve the suppression of viral shedding compared to the current standard of care for genital HSV-2 infections, the nucleoside analog valacyclovir.
