Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that data will be presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during oral and poster presentations at the European Respiratory Society (ERS) Annual Congress September 18 - 22, 2010 in Barcelona, Spain. The data from Inspire's first Phase 3 trial with denufosol (TIGER-1) suggest that denufosol, a novel inhaled ion channel regulator, has the potential to provide benefit in lung function for those patients on minimal pharmacotherapy.
“Cystic Fibrosis: New Targets for Therapy and Impact of Viral Infections”
"Small airways obstruction in CF disease begins early in life and is progressive. Current therapies are directed at treating downstream complications of the disease leading to a large treatment burden. There is a need for novel, disease-modifying therapies that delay onset and progression of disease through early initiation and targeted delivery to the small airways. In the TIGER-1 trial, treatment with denufosol yielded improvement in lung function with limited systemic exposure in stable CF patients taking minimal concomitant medications. Denufosol has potential as an early disease state intervention that may delay CF lung disease progression," stated Felix Ratjen, M.D., Ph.D., Professor of Pediatrics and Division Chief, Respiratory Medicine, University of Toronto, and lead principal investigator of TIGER-2.
The oral presentation, "Denufosol Targets Small Airways and Elicits Improvements in Mild Cystic Fibrosis Patients on Minimal Pharmacotherapy" (F. Accurso, T. Navratil, A. Schaberg, C. Evans, W. Tian, T. Durham, H. Tiddens, F. Ratjen), is being presented by Dr. Ratjen during the session, "Cystic Fibrosis: New Targets for Therapy and Impact of Viral Infections," on Sunday, September 19 from 10:45 am - 12:45 pm local time (4:45 - 6:45 am ET). The presentation highlights a post-hoc analysis of subgroup data from patients in the TIGER-1 trial who were taking zero to two classes of concomitant medications for CF lung disease at baseline>1 /sub>(Forced Expiratory Volume in One Second) of approximately 92%, which was comparable to the ITT population. The treatment effects for denufosol compared to placebo in the subgroup were 100 mL for the change from baseline in FEV1>1/sub>>25%-75%/sub> (Forced Expiratory Flow)>
A poster E-presentation entitled, "Denufosol: A Novel Ion Channel Regulator and Investigational Early Disease State Intervention Therapy for Cystic Fibrosis" (M.J. Stutts, M.S. Cowlen, S.F. Okada, R.C. Boucher), will also be presented during the ERS Annual Congress. This presentation highlights data from pre-clinical studies related to the mechanism of action of denufosol. The data suggest that denufosol increases chloride secretion, inhibits sodium absorption and normalizes airway surface liquid depth in primary epithelial cell cultures from CF patients. These actions support normal airway surface hydration and enhanced mucociliary clearance.
The presentations will be available on Inspire's website, www.inspirepharm.com, following the conference.
: Inspire Pharmaceuticals