NIH Funds Synedgen to Develop a New Drug to Improve Airway Clearance

Helping CF patients breathe easier

September 27, 2013—Claremont CA—Synedgen announces the award of a National Heart Lung and Blood Institute (NHLBI) Small Business Innovation Research grant from the NIH to explore the mechanisms of a natural modified biopolymer to both reduce the viscosity of mucus and the cohesion of biofilms, potentially leading to a pulmonary treatment for patients with cystic fibrosis (CF) to enhance airway clearance and augment the activity of standard therapeutic antibiotics. In preliminary studies, this new approach to controlling molecular interactions in thick sputum and biofilms has shown significant reductions in viscosity and cohesion.

Due to a genetic defect, CF patients have thicker mucus in their lungs and respiratory tract that is very difficult to clear. The resulting accumulation of mucus allows for colonization by biofilm-producing bacteria. The combination of thick mucus and invasive bacterial biofilms can dramatically reduce lung function of CF patients. Because the biofilms provide a sheltered environment to protect bacteria from antibiotic treatments, CF patients typically suffer from persistent and recurrent lung infections.

In partnership with Dr. Steven Rowe, Associate Professor School of Medicine, University of Alabama Birmingham (UAB), and Director of the CFF Therapeutics Development Network’s Center for CFTR Detection, researchers will be assessing a new drug’s role in reducing the viscosity of patient derived sputum. Using human bronchial cell lines that have the CF defect, they will study the drug’s effect on the relationship of sputum viscosity and mucociliary clearance by assessing activity on monolayers of ciliated cells. Since the drug has already been shown to disrupt biofilms, studies to examine the combined effect of the drug with standard antibiotic treatments will explore the effects of this new drug in enhancing the antibiotic therapies used in CF patients.

“Our approach is to tackle biofilms and sputum, reducing their cohesion and viscosity to allow the patient to clear them both. Our preliminary data demonstrates that our polymeric drug both reduces the viscosity of CF sputum and improves sputum mobility in vitro, and separately loosens biofilms,” stated Synedgen President Shenda Baker. “We hypothesize the drug will have significant synergistic activity with traditional antibiotics, and are eager to explore the magnitude and duration of these effects in mucus, biofilms, and in combination.”

In other studies of pathogenic infection and mucosal surface damage, this new drug has been shown to reduce inflammation at the surface. Since cystic fibrosis is a disease severely affected by airway inflammation, future studies will also examine the drug’s potential additional role in mitigating pulmonary inflammation.

“The preliminary data are extremely exciting,” stated Dr. Steven Rowe, “and could provide a new avenue to address mucus stasis in CF lung disease, potentially improving lung health.”

Preliminary results from these studies will be presented in October at the 27^th Annual North American Cystic Fibrosis Conference. Synedgen hopes its new drug will make the sputum flow more freely, break up pathogenic biofilms and also enhance activity of standard antibiotics, providing a new and highly effective pulmonary treatment to help CF patients breathe more easily and combat lung infections.

Research reported in this press release was supported by the National Heart Lung and Blood Institute of the National Institutes of Health under award number 1R43HL118867. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.