An estimated 300 million people worldwide are affected by asthma, causing up to 250,000 deaths per year1,2. Asthma is a personal and public, health and economic burden even in developed countries, where nearly 10% of the population loses substantial time away from work and school. The principal cause of asthma exacerbations, responsible for more than 70%3, is viral respiratory infections. Pulmotect is developing a novel technology to prevent respiratory infections. The lead drug (PUL-042) is a combination of two TLR ligands that stimulates the lungs own innate defense mechanisms, creating a hostile environment for pathogens that can prevent or attenuate respiratory infections. This technology has been validated by both in vitro and in vivo experiments and the drug is already progressing in the regulatory process as a treatment to benefit cancer patients during periods of immunocompromise. In the current proposal, we present plans to accomplish milestones that will advance this technology for commercialization for the asthma market by 1) showing the direct benefit of PUL-042 in mouse asthma models and 2) conducting key development activities to support a clinical trial in patients with asthma. The project is organize into six measurable Specific Aims described in the proposal.
Pulmotect, Inc. is developing novel therapeutics that stimulate the innate immune system to protect against infectious diseases, even in cases of severely compromised immunity. Proof-of-concept data has shown that this technology effectively protects against a broad range of inhaled pathogens, including viral challenges that often cause asthma exacerbations. This project aims to provide significant data to help transition this technology from the lab to the clinic to better assist asthmatics.