NOTA Laboratories, Inc. — Department of Health and Human Services STTR Phase I: NIAID

Description

DESCRIPTION provided by applicant The purpose of the research being proposed is to develop a highly effective nasal rinse that can treat chronic rhinosinusitis CRS in an entirely new way Often CRS is overlooked because it is rarely life threatening CRS is estimated to affect an astounding of the US population with direct costs exceeding $ billion annually and additionally causing million limited activity days according to the CDC Vital and Health Statistics report Coupling said impact with a lack of effective therapies creates a strong opportunity to address a major unmet need in the market Many individuals suffering from CRS exhibit decrease nitric oxide NO concentrations in their sinus cavities NO is a potent and natural antimicrobial molecule that healthy individuals produce at high levels in their sinuses NOTA Laboratories LLC has identified safe and naturally occurring therapeutic agents that can enhance the levels of NO in the sinus airways NO has been proven to stimulate mucociliary clearance and reduces microbial biofilm formation Dr Meyerhoffandapos s laboratory at the University of Michigan has spent andgt years studying the biomedical applications of NO releasing agents materials and has worked with several outside parties to harness the therapeutic properties of NO in the healthcare space NOTA Laboratoriesandapos team of researchers chemists pulmonologists and otolaryngologists believes in this innovative therapy and has the expertise to further its development to treat prevent CRS Using funding from this NIH STTR the company plans to identify and optimize a formulation that incorporates S nitrosoglutathione GSNO along with additives within typical saline sinus rinse solutions and examine the rates of NO release at room temperature and oC using chemiluminescence measurements and test the ability of such NO releasing solutions to disrupt bacterial biofilm kill biofilm bacteriaand increase ciliary beat frequency in vitro using biofilms established on mucociliary differentiated primary sinus epithelial cell cultures The results will drive Phase II studies where NOTA will tes the optimal nasal rinse formulations derived from this Phase I study in suitable animal models as a prelude to clinical trials in collaboration with a research team at the University of Michigan Medical School PUBLIC HEALTH RELEVANCE Chronic rhinosinusitis CRS affects an estimated of the US population with direct costs exceeding $ billion annually Because currently marketed therapies are of limited effectiveness this unmet need represents an immense commercial opportunity Research has shown that CRS patients have reduced nitric oxide NO levels in their sinus cavities and this likely contributes to formation of S aureus and other microbial biofilms that cannot be effectively eradicated by antibiotics Through the research described in this application NOTA Laboratories will develop an inexpensive but effective topical sinonasal spray or rinse solution product containing S nitrosoglutathione GSNO an endogenous carrier of NO in humans to increase levels of NO in the sinus cavities of CRS patients and thereby treat prevent CRS in a large number of patients