ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialisation of targeted antiviral therapies, announced that the first patient has been enrolled in its pivotal phase 3 clinical study, study 007, of FV-100 to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
The first patient in the study has been enrolled at Center for Clinical Studies in Houston, Texas. The study will build upon prior clinical results for FV-100, including phase 1 trials and a large phase 2 clinical trial in shingles patients, which demonstrated favourable safety and tolerability for FV-100.
James Sapirstein, chief executive officer of ContraVir, said, "We are pleased to enroll the first patient in the phase 3 study and to move forward in our efforts to develop treatment options for patients with shingles and acute shingles-associated pain. The enrollment is an important milestone for ContraVir as we advance our current pipeline as this brings us one step closer to commercialisation."
The pivotal study 007 will compare FV-100 to valacyclovir (Valtrex) with the reduction in the incidence of shingles-associated pain, PHN, as a primary endpoint. It is a multi-center, randomized, double-blind, parallel-group, comparative study in up to 200 centres in the US. The study is comprised of three arms: FV-100 400mg QD, FV-100 400mg BID, and valacyclovir 1000mg TID. Approximately 825 patients are expected to be analysed for a seven-day treatment period, and follow up through day 120.
Stephen Tyring, M.D., Ph.D., primary investigator of study 007, added, "We are proud to acknowledge that the first patient entered the trial from one of our network clinics. We believe this is an important study in our continuing efforts to improve the lives of shingles patients all over."
Herpes zoster, commonly known as shingles, is a neurological disorder caused by the reactivation of varicella zoster virus (VZV), which causes chickenpox. There are over an estimated four million cases of shingles in the US, Europe, and Japan each year, primarily in the aging adult population. Symptoms include localised lesions and pain. The majority of patients experience pain for several weeks in connection with their active infection. Pain that persists for over three months is referred to as PHN, which occurs in approximately 15-20 per cent of all shingles patients. PHN-specific symptoms include mild to excruciating pain long after the shingles rash resolves and disruption of sleep, mood, work, and daily living. Over 65-70 per cent of shingles patients suffer from PHN for 30 days or more, and can last for 2-3 years.
FV-100 is a fast-acting, low-dose, oral antiviral therapy for treatment of herpes zoster or shingles. In addition to its potent antiviral activity, FV-100 has demonstrated an ability to reduce the incidence and severity of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN. In phase 2 trials, FV-100 demonstrated a clinically meaningful 37 per cent reduction in the incidence of PHN versus valacyclovir (Valtrex), and favourable safety and tolerability.