Synedgen to Report Promising Research at National Cystic Fibrosis Conference

Potential Treatment to Improve Lung Function and Antibiotic Effectiveness in Patients with Cystic Fibrosis

October 8, 2013—Claremont CA—Excessive viscoelastic mucus contributes to airways obstruction and progression of Cystic Fibrosis (CF) lung disease. Viscous mucus also limits mucociliary clearance and facilitates bacterial biofilm formation. Complications due to biofilm infections in CF patients continue to rise, amid diminishing therapeutic options and the expanding threat of multi-drug resistance. Current therapies intended to improve lung function address components in CF mucus, however these treatments are limited in the magnitude of their activity and by the presence of recalcitrant biofilms.

Synedgen has developed a soluble, nontoxic polycationic polysaccharide, PAAG, as a potential treatment to both reduce mucus viscosity and the cohesion of biofilms in the lungs of CF patient, ultimately allowing for better clearance of these thick layers and improved pulmonary function.

Synedgen will report compelling data on its lead compound demonstrating a significant reduction in the viscosity of human CF sputum and a simultaneous reduction of biofilm cohesion from lethal CF bacteria. These results will be highlighted at a poster session during the 27th Annual North American Cystic Fibrosis Conference held October 17-19, 2013 in Salt Lake City, Utah. The preliminary results have already led to additional funding by the NIH.

Synedgen’s VP of Research Stacy Townsend PhD will present “PAAG Facilitates Synergistic Antibiofilm Activity Against Pseudomonas Aeruginosa and Reduces Intracellular Persistence of Burkholderia Cepacia”.

Studies examined the synergy of PAAG and tobramycin against biofilms of P. aeruginosa, a common, recalcitrant bacteria in the CF patient lung. These studies indicated that PAAG and tobramycin concentrations were synergistic against P. aeruginosa biofilms showing at least a 2-log reduction beyond tobramycin alone. Another bacterium, Burkholderia, is less common but hides from antibiotics inside macrophages where it develops a protective sanctuary. PAAG was also shown to prevent Burkholderia from hiding in macrophages, thus making it more susceptible to antibiotics.

Drs. John Clancy (Research Director, Division of Pulmonary Medicine Professor, UC Department of Pediatrics, University of Cincinnati) and Steven Rowe (Associate Professor School of Medicine, University of Alabama Birmingham, and Director of the CFF Therapeutics Development Network’s Center for CFTR Detection) will also report on PAAG’s ability to reduce the viscosity and elasticity of CF sputum in a poster entitled “PAAG Improves Cystic Fibrosis Sputum Viscosity and Elasticity Ex Vivo”. These researchers collected fresh samples of CF patient sputum from enrolled patients. Sputum was incubated with various concentrations of PAAG and controls. Shear dependent viscosity and elasticity were measured. PAAG markedly reduced viscosity and elasticity with a robust activity. The details will be presented in Salt Lake next week.

“These studies add to our growing in vitro data of PAAG’s effectiveness and will support our efforts to move into clinical studies to show activity in the lungs to loosen biofilms and to potentiate antibiotic activity,” remarked Synedgen’s VP of Research Stacy Townsend.

“PAAG is promising as a treatment that goes beyond the current mucolytic drugs. We continue to evaluate its effects on mucociliary transport, inflammation and antibiotic synergy. Not only does PAAG portend great promise for CF patients, it has direct application to the treatment of chronic obstructive pulmonary disease (COPD), added Synedgen President Shenda Baker. “This data and results anticipated from upcoming research will help bring this new product closer to patient studies.”

This research was funded by Synedgen. This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Synedgen’s management and are subject to significant risks and uncertainties. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from those anticipated, we cannot assure that the results or developments anticipated by management will be realized or will have the expected consequences to, or effects on, us or our business prospects or financial condition.