US-based immunotherapeutics and preventative vaccines developer NovaDigm Therapeutics has reported positive results from its Phase IIa clinical trial of NDV-3A to treat recurrent vulvovaginal candidiasis (RVVC).
Developed as an immunotherapeutic vaccine, the NDV-3A is composed of a recombinant form of the fugus, Candida albicans agglutinin-like sequence 3 (Als3) surface protein, which triggers Candida adherence to and invasion of human endothelial cells.
The multi-centre, double-blind, randomised, placebo-controlled Phase IIa trial was designed to test the safety, tolerability, immunogenicity and efficacy of NDV-3A.
A total of 188 patients were enrolled in the trial and administered with a single dose of either 300µg NDV-3A immunotherapy or a placebo.
The trial was primarily focused to determine the safety and tolerability of a single, intramuscular dose of NDV-3A compared to placebo, in patients who experienced at least three episodes of VVC over the past 12 months.
The secondary goals were to examine the humoral and cellular immune responses and various measures of efficacy in reducing the frequency and / or severity of recurrences over a 12-month period.
Results suggested that the trial achieved its primary endpoints of safety and tolerability exhibiting no significant difference between NDV-3A and placebo for injection site reactions and systemic reactions of grade three or more.
A single dose of NDV-3A has induced a fast immune response.
Drexel University College of Medicine obstetrics and gynecology professor and Phase IIa trial principal investigator Dr Paul Nyirjesy said: “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.
“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.”
Within preclinical studies, the vaccine conferred a high efficacy rate compared to placebo while resisting highly virulent doses of Candida albicans or against one of several strains of Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA).