Clinical Development of a Therapeutic Agent for COPD

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DESCRIPTION (provided by applicant): Hypersecretion of mucus into the respiratory airways is a major contributing factor in several lung diseases, including chronic pulmonary disease (COPD), asthma, cystic fibrosis, allergic rhinitis, and bronchiectasis. Despite the obvious medical importance, there presently are no effective therapies to control excess mucus secretion in these diseases, and very few potential therapeutic targets. We discovered that a specific protein called MARCKS is a key molecule in the mucus secretary pathway. Based on this finding BioMarck developed a novel peptide, BIO-11006, which inhibited mucus hypersecretion as well as release of inflammatory mediators in human airway epithelial cells in culture and in various rodent models. BIO-11006, being a dual function inhibitor mucus secretion and inflammation, is an ideal drug to potentially treat various lung diseases including COPD. With funding from SBIR grants, BioMarck continued work on this project and has recently successfully completed, under an active IND, a 21-day proof-of-concept Phase 2A clinical study in 172 COPD patients suffering from chronic bronchitis with its lead compound BIO-11006. This SBIR Phase II Bridge grant application will allow BioMarck to undertake a 90-day Phase 2B multi center, double blind, dose selection clinical study with BIO-11006 with 300 COPD patients suffering from chronic bronchitis. A successful completion of the proposed project will allow BioMarck to select a dose level for the final Phase 3 clinical study. Worldwide the social and economic burden of COPD is enormous. COPD, being the 3th. leading cause of death, accounts for over 5 million deaths worldwide. Although there are more than 25 different drugs currently available in the market, the patients and the care providers are desperate for effective drugs for the treatment of COPD. BIO- 11006, by reducing both excess mucus and airway inflammation, has the potential to be a first in class drug to effectively treat this patien population.