AiCuris treatment granted fast track designation by FDA

Drug discovery and development company, AiCuris, has been granted fast track designation by the US Food and Drug Administration (FDA) for oral pritelivir — its lead candidate for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised adults.

Oral pritelivir is a small molecule helicase-primase inhibitor with a novel mode of action. It is currently under evaluation in a clinical Phase II study, PRIOH-1, for its efficacy and safety in comparison with iv foscarnet, a virostatic agent mainly used for the treatment of herpes viruses resistant to other antiviral drugs.

Fast track designation is designed to assist the development, review and speed up the approval process of drugs to treat serious conditions and fill an unmet medical need. Products that are part of the FDA’s fast track programme may be eligible for an accelerated approval and priority review is specified criteria are met.

“The decision by the FDA to grant fast track designation to oral pritelivir underscores that our product might fill the major need for innovative, more efficacious therapies for immunocompromised patients with HSV infections that have become resistant to standard treatments,” commented Dr Holger Zimmermann, CEO of AiCuris Anti-infective Cures. “Fast Track designation should enable us to further accelerate the development of pritelivir, which already has shown that it may have the potential to become an important alternative to current treatments as a highly effective and convenient oral therapy.”