US-based biopharmaceutical company ContraVir has extended the patient enrolment in its ongoing Phase III trial of antiviral candidate FV-100, to treat shingles-associated pain known as post-herpetic neuralgia (PHN).
The extension was to accommodate the changing shingles population as was revealed in clinical practice and enrol the clinically relevant patients into the study.
In the trial, the minimum age of male and female patients who can be enrolled was lowered from 50 to 30 years, representing the age at which many patients currently get shingles.
Study investigators will now enrol patients who are afflicted with shingles within five days of lesion appearance, when it was previously restricted to within three days.
ContraVir chief medical officer John Sullivan-Bolyai said: "Recent data show that the average age of shingles patients is now approximately 50 years, which is significantly younger than it has been historically, and it is important for our trial to be aligned with the current patient population.
"Furthermore, the majority of patients do not immediately recognise and seek medical treatment for shingles symptoms, rather opting to ‘wait and see’ if the symptoms get worse while taking at-home therapies such as analgesics or topical steroids.
"It was necessary to remove certain exclusion criteria from our protocol in order to account for these clinically relevant patient behaviours, which more accurately represent how patients arrive at the clinic with a potential shingles diagnosis."
Contravir’s FV-100 is a fast-acting, low-dose, once-daily, oral antiviral therapy to treat herpes zoster, or shingles, an infection triggered by the reactivation of chicken pox virus.