NovaDigm Therapeutics has started a Phase Ib/IIa clinical trial of its NDV-3 vaccine, which is being developed to prevent episodes of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC).
Under the trial, which is a multi-center, double-blind, randomized, placebo-controlled study, the company will enroll 189 patients at multiple sites in the US.
The study intends to estimate the effect of a single, intramuscularly-administered dose of NDV-3, as compared to placebo, by evaluating safety and tolerability, as well as humoral and cellular immune responses, over a 12-month period.
The study will also summarize recurrence of VVC over both a six- and 12-month period, time-to-onset of first VVC episode and severity of subsequent VVC episodes.
According top the company, NDV-3 is a vaccine candidate containing a recombinant form of the Candida albicans surface protein Als3, which facilitates Candida adherence to and invasion of human endothelial cells.
NovaDigm CEO Timothy Cooke said an active immunotherapy approach like NDV-3 has potential to address the significant need for improved long-term control of RVVC, the market which is expected to reach more than $1bn globally.
"The initiation of this trial follows a preclinical study in a model of VVC, which demonstrated that NDV-3 induced potent and protective immune responses, as well as two successful Phase 1 studies, which demonstrated that NDV-3 was safe, well-tolerated and induced strong antibody and T-cell immune responses in healthy adults," Cooke added.
"In addition to RVVC, NovaDigm is also continuing to advance NDV-3 for other infectious disease indications, such as skin and soft tissue infections caused by drug-resistant Staphylococcus aureus and nosocomial infections caused by drug-resistant Staphylococcus aureus and Candida."
NDV-3, which was developed in the labs of NovaDigm's scientific founders at the Los Angeles BioMedical Research Institute, is the first vaccine to show preclinical "cross-kingdom" protective efficacy against both fungal and bacterial pathogens.
