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Novel COG Compounds to Treat Asthma

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL114296-01
Agency Tracking Number: R43HL114296
Amount: $261,824.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA11-096
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
79 T. W. Alexander Drive
United States
DUNS: 141881727
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 765-0028
Business Contact
Phone: (919) 765-0028
Research Institution

DESCRIPTION (provided by applicant): Our overall goal is to market a COG compound (aka. apoE-mimetic peptides) for the treatment of patients with asthma. Cognosci has discovered, patented and published a novel series of COG compounds which are functionalmimetics of apolipoprotein-E. These COG compounds have profound anti-inflammatory activities in a wide variety of cell-based and animal-based models of human disease conditions (Vitek et al. 2011, Christensen et al. 2011, Li et al. 2008, Lynch et al. 2003,and others). The COG compounds are also extremely well tolerated in mice, rats and dogs following repeated daily dosing for as many as 90 days that was tested. In a totally unanticipated publication, Levine and colleagues at National Institutes of Heart,Lung and Blood (NHLBI) independently found that apoE-130-149 significantly reduced the signs, symptoms and characteristics of asthma in a house dust mite-induced model of asthma in mice. ApoE-130-149 is known to us as COG130, a patented composition of matter owned by Cognosci. These events have now put us in a unique position to verify and extend Levine's pioneering work in this Phase I proposal so that we can: 1) show that COG130 can be efficiently nebulized into an aerosol, and that the inhaled aerosol is well tolerated in single and repeat dosing in mice and 2) that inhaled COG130 produces a dose-dependent reduction of asthmatic characteristics in a House Dust Mite-induced model of asthma in mice. The data generated from the successful completion of theexperimental work plan in this proposal will lay the foundation for the medical, commercial and regulatory requirements that Cognosci will need to fully develop to move a COG compound into clinical use for the treatment of asthma. PUBLIC HEALTH RELEVANCE: Asthma is a highly prevalent disease affecting 300 million patients worldwide, with 24 million in the United States including 10 million children, and its numbers appear to be increasing. Sadly, in spite of our best efforts to provide medical care, 5000 asthmatic patients die each year from their disease (about 100 per week). Clearly we need new and more effective treatments to control asthma, particularly severe asthma that includes acute life-threatening situations. This proposal is to test atotally novel approach, where COG compounds, which are peptide mimetics of apolipoprotein-E, confer profound anti-inflammatory activity, reduce airway hyperresponsiveness and reduce airway remodeling that is associated with the asthmatic condition in mousemodels. Based on the data collected in these proposed studies, we will be able to define how COG130 aerosols are tolerated in healthy mice and how they can reduce the signs and symptoms of disease in a house dust mite-induced model of asthma in mice. These studies are part of the foundation that we need to build to complete FDA required safety and toleratiblity studies in animals as a prelude to clinical testing in human asthmatic patients.

* Information listed above is at the time of submission. *

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