BOSTON - April 25, 2018 - NovaDigm Therapeutics, a company developing innovative immuno-therapeutics and preventative vaccines for fungal and bacterial infections, today announced the publication of data from a Phase 2a study of its NDV-3A vaccine program in the journal Clinical Infectious Diseases. The data demonstrate that a single dose of NDV-3A with alum adjuvant was safe, well-tolerated, immunogenic and efficacious, leading to reduced recurrences of vaginitis in patients with recurrent vulvovaginal candidiasis (RVVC). NDV-3A is the company's lead development candidate to potentially treat or prevent diseases caused by fungal and bacterial pathogens, including antimicrobial-resistant strains.
The article, titled "A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis - A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trials," was published online in the journal Clinical Infectious Diseases . The article was published with a concurrent editorial entitled, "A Therapeutic Vaccine for Recurrent Vulvovaginal Candidiasis," by Arturo Casadevall, M.D., M.S., Ph.D., Chair, Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health and Liise-anne Pirofski, M.D., Chief, Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine .
"There is a growing need for vaccines that can prevent or treat conditions caused by Candida species, such as Candida albicans, the major causative agent of RVVC," commented John Edwards, M.D., first author of the study, Emeritus Chief, Division of Infectious Disease at Harbor-UCLA Medical Center and a scientific founder of NovaDigm. "The positive results in patients with RVVC represent the first demonstration of efficacy for any antifungal vaccine. These results encourage further development of NDV-3A against life-threatening invasive Candida infections, including those by the recently emerging, highly drug-resistant Candida auris."
Nine million women in the United States (11%) report having recurrent yeast infections, with approximately seven million (9%) experiencing RVVC, which has been defined as having three or more episodes per year. Approximately 90% of patients report onset of RVVC prior to the age of 40 years . Many of these women experience frequent episodes of pain and discomfort, high rates of depression and a reduced overall quality of life . While current therapies are effective at controlling acute infections, they do not control recurrences without chronic antifungal suppression, which is not widely used due to potential adverse events.
"Women who have recurrent vulvovaginal candidiasis have limited options to maintain control of this chronic condition, which can have a significant impact on their health and overall quality of life," said Paul Nyirjesy, M.D., Professor of Obstetrics and Gynecology and of Medicine at Drexel University College of Medicine, who was a principal investigator in the Phase 2a study. "The results of this trial demonstrate increases in recurrence-free time out to 12 months for younger women based on patient symptom scores following a single dose of NDV-3A. This finding represents a potential breakthrough for an immunotherapeutic approach to treating these patients."
Top line results reported in August 2016 show the study of 188 patients met its primary endpoint of safety and tolerability. There were no significant differences between NDV-3A and placebo for injection site reactions and systemic reactions of grade 3 or greater. A single dose of NDV-3A generated rapid and robust immune responses. Exploratory efficacy measures based on patient-reported symptom scores showed a higher proportion of patients in the NDV-3A group with no recurrences at the 12-month follow-up period compared to the placebo group (p=0.10). Younger patients showed higher efficacy rates. In patients under 40 years of age (77% of the study population), 42% of NDV-3A recipients were recurrence-free at 12 months post-vaccination compared to 22% of placebo recipients (p=0.03). Patients in this age group receiving NDV-3A also showed a doubling in median time to first recurrence (210 days) compared to placebo recipients (105 days).