Valnivudine™ (formerly FV-100)

Valnivudine™ Overview

We are developing Valnivudine™ as a fast-acting, low-dose, once-daily, oral antiviral therapy for the treatment of herpes zoster, or shingles, an infection caused by the reactivation of the varicella zoster (chicken pox) virus. In addition to its potent antiviral activity, Valnivudine™ has demonstrated an ability to reduce the incidence and severity of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.

We are currently conducting a pivotal Phase 3 trial that will compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.

Examples of Shingles Lesions

Shingles and Shingles Pain

Driven primarily by the aging adult population, the rate of shingles is increasing steadily. Recent research estimates there are more than four million cases of singles each year in the major markets of the U.S., Europe, and Japan, of which more than half occur in the U.S. Further, approximately two-thirds of shingles patients suffer from pain for 30 days or longer. Learn more about shingles and shingles pain >>

The pain associated with an episode of shingles is attributed to both the damage caused to the affected nerves by the replication of varicella zoster virus and the inflammatory response associated with the infection.

For many patients, shingles-associated pain does not resolve when the lesions heal and the inflammation subsides, but, rather, continues for months, or possibly years. Shingles-associated pain, or PHN, is the most common and clinically relevant complication of shingles.

Post-herpetic Neuralgia (PHN)
  • Mild to excruciating pain long after shingles rash resolves
  • >65-70% of shingles patients suffer from PHN for 30 days or more; can last for 2-3 years
  • Disrupts sleep, mood, work, and activities of daily living
U.S. Prescriptions and Market Share (2012)

Source: NPA Data – 12 months ending 12/31/2012

Valnivudine™ Clinical Highlights

Phase 1 and 2 trials of Valnivudine™ were successfully completed. We are currently conducting a pivotal Phase 3 trial in patients with shingles to further explore Valnivudine’s™ potential ability to reduce shingles pain.

Demonstrated Safety and Efficacy
  • >350 patients treated with Valnivudine™
  • Clinically meaningful reduction in PHN occurrence versus valacyclovir
  • Meaningful reduction in time to resolution of clinically significant pain
  • 8-10% fewer patients required narcotics for pain control
  • Safety similar to other antivirals
Reduction in PHN at 90 days vs. Valacyclovir

In Phase 2 trials, Valnivudine™ demonstrated a clinically meaningful 37% reduction in the incidence of PHN versus valacyclovir (Valtrex®).

Potential for Market Differentiation

  • Rapid onset of action for quick pain relief
  • Higher potency vs. approved agents against herpes zoster
  • Efficacy profile superior to valacyclovir
  • Potential for QD dosing vs. 3-5x daily for valacyclovir
  • No dose adjustments needed for patients with renal insufficiency
Potential Advantages of Valnivudine™ over Currently Marketed Shingles Therapies

Click to Enlarge

Phase 3 Clinical Study

ContraVir’s pivotal Phase 3 study seeks to compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.

Learn about the Valnivudine™ Clinical Trial at GotShingles.com >>

Phase 3 Study Design
  • Multi-center, randomized, double-blind, parallel-group, comparative study (Valnivudine™ vs. valacyclovir)
  • Up to 200 centers (U.S. only)
  • Three-arm study: Valnivudine™ 400mg QD, Valnivudine™ 400mg BID, Valacyclovir 1000mg TID
  • 985 patients estimated with 275 patients per arm
  • Patients aged 30 years and older
  • Seven day treatment period; follow up through day 120

Scientific Research

Pharmacokinetic data from completed Phase 1 and 2 clinical trials suggest that Valnivudine™ has the potential to demonstrate antiviral activity when dosed orally once-a-day at significantly lower blood levels than acyclovir, valacyclovir, and famciclovir, the FDA-approved drugs used for the treatment of shingles.

Journal of Antimicrobial Chemotherapy (2009) 64, 671–673, Advance Access publication August 13, 2009
McGuigan C, Balzarini J.

22nd Annual International Conference on Antiviral Research (ICAR), Miami Beach, FL; May 3 – 7, 2009
Dr. Mark Matson et al.

22nd Annual International Conference on Antiviral Research (ICAR), Miami Beach, FL; May 3 – 7, 2009
Dr. Mark Matson et al.