24 April 2018 - - Boston, Massachusetts-based immuno-therapeutics and preventative vaccines developer NovaDigm Therapeutics has initiated a Phase 2a study evaluating NDV-3A for the reduction of Staphylococcus aureus (S. aureus) colonization in a high-risk population of military trainees, the company said.
The study is being conducted with the Uniformed Services University of the Health Sciences and is enrolling US Army Infantry trainees at Fort Benning, GA.
NDV-3A, the company's lead development candidate to potentially treat antimicrobial resistant fungal and bacterial pathogens, has been demonstrated to be both safe and highly immunogenic in healthy human volunteers.
Preclinical studies of NDV-3A have demonstrated its effectiveness in reducing the impact of bloodstream and skin infections caused by S. aureus.
The investigative team has initiated enrollment for the individually-randomized, double-blind, placebo-controlled clinical trial to assess the safety, immunogenicity and efficacy of NDV-3A in reducing nasal/oral acquisition of S. aureus.
NDV-3A is being developed as an immunotherapy and as a preventative vaccine for infections caused by several species of the fungus Candida, including Candida albicans, multidrug-resistant Candida auris and the bacterium Staphylococcus aureus, including MRSA.
NovaDigm is developing innovative immunotherapeutic and preventative vaccines to protect patients from fungal and bacterial diseases, which can be recurrent, drug-resistant and in some cases, life-threatening.
The company's lead development candidate, NDV-3A, is the first vaccine to demonstrate preclinical efficacy in reducing the severity of disease caused by both fungal and bacterial pathogens.