ContraVir Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to begin a Phase III trial of its lead drug candidate, FV-100, for the prevention of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
FV-100 is a fast acting, low dose, once-daily oral antiviral agent under development to treat herpes zoster (shingles), an infection caused by the reactivation of varicella zoster virus.
The agency has agreed to, with minor modifications, the company’s proposed clinical protocol, which is designed as a pivotal Phase III trial.
The company is exploring the potential of FV-100 to prevent the severe and long-lasting effects of this condition. Currently, there are no approved antiviral therapies to prevent PHN and it remains a major unmet medical need.
ContraVir chief executive officer James Sapirstein said: "We are encouraged by the added clarity and favorable position the FDA has taken regarding our clinical strategy for FV-100, and we look forward to initiating the Phase 3 trial in the second quarter 2015.
"The proposed plan for clinical development of FV-100, agreed to by the FDA, significantly shortens the development pathway for FV-100. This will save ContraVir considerable time and money."
The company said that the new Phase III trial will build upon prior clinical results for FV-100, including Phase I trials as well as a large Phase II clinical trial in shingles patients, which showed excellent safety and tolerability for FV-100.
Apart from direct antiviral activity, FV-100 has showed the potential to reduce the incidence of debilitating shingles-associated pain, known as post-herpetic neuralgia (PHN).
The company is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir DF (Viread).