Vulvovaginal candidiasis (VVC), also called vaginal yeast infections, is a condition that affects approximately 75% of the female population between puberty and menopause. Approximately five million women in the U.S. suffer from recurrent vulvovaginal candidiasis (RVVC), which is defined as four or more episodes of VVC in a year. An additional two million women in the U.S. have reported having three VVC episodes a year and may also be candidates for a vaccine.1
NDV-3A is well positioned to address the significant unmet need to control episodes of vulvovaginal candidiasis in patients diagnosed with RVVC. A preclinical study of NDV-3 in a model of vulvovaginal candidiasis concluded that vaccination with NDV-3 induced potent and protective immune responses.2 Based on these positive results, NovaDigm conducted a multi-center, double-blind, randomized, placebo-controlled Phase 1b/2a clinical trial to evaluate the safety, tolerability, immunogenicity and efficacy of NDV-3A in patients diagnosed with RVVC.3,4 The study showed statistically significant measures of efficacy based on patient symptom scores over the course of the 12-month follow up period.
Current RVVC treatments are primarily azole-based antifungal drugs, which are available over-the-counter and by prescription as either topical creams or oral capsules. While these treatments are fairly effective at controlling acute infections, they do not prevent future infections unless taken chronically. Additionally, there is a cost burden to patients and payors associated with treating RVVC, with estimated total VVC (including RVVC) U.S. health care costs of $4-5 billion per year.1 RVVC symptoms place a significant burden on patients’ quality of life, affecting their social and sex lives. Market research indicates that U.S. patients, physicians and payors desire preventative options for RVVC, highlighting the potential for NDV-3 to address this key unmet need. Based on this market research study, the annual projected sales for a VVC vaccine in the U.S. alone is estimated to be $500 million to $1 billion.3
- L.E.K. Consulting primary research on vulvovaginal candidiasis conducted in 2,400 US women, 2011.
- Ibrahim AS, Luo G, Gebremariam T, Lee H, Schmidt CS, Hennessey JP, French SW, Yeaman, MR, Filler SG, and Edwards, JE Jr., NDV-3 protects mice from vulvovaginal candidiasis through T- and B-cell immune response. Vaccine 2013;31L5549-5556.
- clinicialtrials.gov Identifier: NCT01926028.
- Edwards, J.E., Jr, Schwartz, M.M., Schmidt, C.S., Sobel, J., Nyirjesy, P., Schodel, F., Marchus, E., Lizakowski, M., DeMontigny, E.A., Hoeg, J., Holmberg, T., Cooke, M.T., Hoover, K., Edwards, L., Jacobs, J., Sussman, S., Augenbraun, M., Reagan, R., Drusano, M., Yeaman, M.R., Ibrahim, A.S., Filler, S.G., Hennessey, J.P., Jr. (2018) A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis; A Phase 2 Randomized, Double-blind, Placebo-controlled Trial. Clinical Infectious Diseases, ciy185, https://doi.org/10.1093/cid/ciy185
- L.E.K. Consulting primary research on vulvovaginal candidiasis, 2011 and NovaDigm estimates.