NovaDigm Therapeutics, a company developing innovative immuno-therapeutics and preventative vaccines for fungal and bacterial infections, today announced the initiation of 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 study is being conducted with the Uniformed Services University of the Health Sciences (USU) and is enrolling U.S. Army Infantry trainees at Fort Benning, GA. NDV-3A is the company's lead development candidate to potentially treat antimicrobial resistant fungal and bacterial pathogens.
"Military recruits who are colonized with Staph aureus are at increased risk for skin infections, which can manifest in various ways including benign boils, cellulitis or more severe, invasive soft-tissue infections. The goal of this study is to reduce colonization during basic training with the NDV-3A vaccine," said Timothy Cooke, CEO of NovaDigm. "Following on the results of this trial, a larger study would be conducted to demonstrate a reduction in skin infections. We look forward to continuing our collaboration with the Department of Defense, which plays a critical role in the support of innovative approaches to address antimicrobial-resistant pathogens."
Military recruits are known to be at increased risk for S. aureus colonization and infection, attributable to a number of factors in the military training environment that may enhance the acquisition and transmission of S. aureus (e.g. limited access to hygiene during field training, crowding, etc.). The development of countermeasures to treat and prevent infections affecting medical readiness, such as those caused by S. aureus and MRSA (methicillin-resistant S. aureus), are an important focus for the military. NDV-3A 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. With a target enrollment of approximately 400 participants, infantry trainees from four classes will be recruited for the study, with receipt of NDV-3A occurring shortly after arrival at Fort Benning. Follow-up visits will occur throughout the 14-week training cycle to assess S. aureus colonization status of study participants.