NovaDigm Therapeutics has announced the publication of positive data from a Phase IIa study of its NDV-3A vaccine as a treatment for recurrent vulvovaginal candidiasis (RVVC).
NDV-3A is the company’s lead development candidate for the treatment or prevention of diseases caused by fungal or bacterial pathogens, including antimicrobial-resistant strains. It contains a recombinant form of the Candida albicans agglutinin-like sequence 3 (Als3) surface protein, which enables the infection’s invasion of human endothelial cells. Data from the trial found a single dose of NDV-3A with alum adjuvant to be safe, well-tolerated and to effectively reduce instances of RVVC in patients.
Top-line results from the study in August 2016 found it had achieved its primary endpoint of safety and tolerability. No significant differences were found between NDV-3A and placebo for injection site reactions and systemic reactions of grade 3 or greater. In participants under the age of 40, 42% of NDV-3A recipients were recurrence-free at 12 months following vaccination, compared to 22% of placebo recipients.
"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," the study’s first author Dr John Edwards said.
"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."
In the US, nine million women (11%) report recurrent yeast infections, while around seven million (9%) experience RVVC, defined as three or more episodes per year. Approximately 90% of these patients report RVVC prior to the age of 40. The condition causes not only physical discomfort but also often leads to high rates of depression and a reduced overall quality of life.
Current therapies for the condition work to control acute infections, however, they use chronic antifungal suppression which has a high potential for adverse effects.
"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," principal investigator Dr Paul Nyirjesy said.
"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."
NovaDigm is known for its work developing and producing immunotherapies and preventative vaccines for fungal and bacterial infections. Findings from its recent study were published in the journal Clinical Infectious Diseases.