SBIR-STTR Award

Preventing Asthma Exacerbations by Reducing Viral Respiratory Infections
Award last edited on: 11/17/14

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,286,924
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Brenton Scott

Company Information

Pulmotect Inc

3900 Essex Lane Suite 250
Houston, TX 77027
   (713) 579-9226
   bscott@pulmotect.com
   www.pulmotect.com
Location: Single
Congr. District: 07
County: Harris

Phase I

Contract Number: 1R43HL115903-01
Start Date: 9/1/12    Completed: 8/31/13
Phase I year
2012
Phase I Amount
$301,296
Asthma is a leading cause of respiratory disease worldwide, with an estimated 300 million people affected and up to 250,000 deaths per year. Even in developed countries, asthma continues to be a burden for nearly 10% of the population with substantial time lost from work and school and considerable health care expenditures. The principal cause of asthma exacerbations is viral respiratory infections, estimated to be responsible for more than 70%. Pulmotect's Solution: Pulmotect has identified and is developing a novel technology to prevent respiratory infections. The lead drug (PUL-042) is a combination of two TLR ligands that stimulates the lung's own innate defense mechanisms to create a hostile environment for pathogens and prevent or attenuate respiratory infections. Both in vitro and in vivo experiments have been completed to validate this technology and the drug is progressing through the regulatory process for a treatment to benefit cancer patients during periods of immunocompromise. The focus of this proposal is to accomplish key milestones that will further transition this technology for commercialization for the asthma market by showing the direct benefit of PUL-042 in mouse asthma models. The project is organized into three measurable Specific Aims that include evaluating the safety and efficacy of PUL-042 in a mouse models of asthma.

Public Health Relevance:
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. This project will provide significant data to help transition this technology from the lab to the clinic for asthmatics. This work will leverage ongoing activities in developing the technology for cancer patients.

Public Health Relevance Statement:
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. This project will provide significant data to help transition this technology from the lab to the clinic for asthmatics. This work will leverage ongoing activities in developing the technology for cancer patients.

NIH Spending Category:
Asthma; Infectious Diseases; Lung; Prevention

Project Terms:
Address; Aerosols; Affect; airway hyperresponsiveness; Allergic; Animal Model; Asthma; asthmatic patient; Attenuated; Biological Markers; Breathing; Cancer Patient; Cavia; Cessation of life; Clinic; commercialization; Communicable Diseases; Consultations; Data; Data Set; Defense Mechanisms; design; Developed Countries; Development; Environment; eosinophilic inflammation; Extrinsic asthma; Health Expenditures; Immune system; Immunity; Immunocompromised Host; In Vitro; in vivo; interest; Lead; Ligands; lost work time; Lower Respiratory Tract Infection; Lower respiratory tract structure; Lung; Lung diseases; Marketing; Measurable; Measures; Metaplasia; Modeling; mouse model; Mucous body substance; Mus; new technology; novel therapeutics; pathogen; Pharmaceutical Preparations; Phase; phase 1 study; Phase I Clinical Trials; Phenotype; Population; prevent; Process; research study; Resistance; Respiratory distress; Respiratory Tract Infections; response; Risk; Safety; Schools; Sendai virus; Small Business Innovation Research Grant; Solutions; Technology; Toxic effect; Viral; Virus; Virus Diseases; Work

Phase II

Contract Number: 2R44HL115903-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2014
Phase II Amount
$985,628
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.

Thesaurus Terms:
Aerosolized;Affect;Airway Hyperresponsiveness;Analytical Method;Asthma;Attenuated;Breathing;Cancer Patient;Capital;Cessation Of Life;Characteristics;Chemicals;Chemistry;Clinic;Clinical Research;Clinical Trials;Commercialization;Communicable Diseases;Data;Defense Mechanisms;Developed Countries;Development;Dose;Drug Design;Drug Development;Economic Burden;Effectiveness;Environment;Future;Health Economics;Human;Immune System;Immunity;Immunocompromised Host;In Vitro;In Vivo;Institutional Review Boards;Investigational New Drug Application;Lead;Ligands;Lung;Marketing;Measurable;Meetings;Modeling;Mus;New Technology;Novel Therapeutics;Outcome;Pathogen;Patients;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;Phenotype;Population;Positioning Attribute;Powder Dose Form;Preparation;Prevent;Process;Product Development;Protocol Development;Public Health Medicine (Field);Public Health Relevance;Qualifying;Reference Standards;Regimen;Research Study;Resistance;Respiratory;Respiratory Tract Infections;Response;Safety;Safety Study;Schools;Small Business Innovation Research Grant;Solutions;Technology;Time;Toxic Effect;Toxicology;Treatment Planning;Viral;Virus;Virus Diseases;Work;