Durham-based Inspire Pharmaceuticals has begun a second Phase III trial for its cystic fibrosis treatment, denufosol.
"Denufosol could be the first early intervention therapy available to CF patients that affects an early step in the progression of the disease," said Felix Ratjen, M.D., Ph.D., the lead principal investigator for the study. Ratjen is Professor of Pediatrics and Division Chief, Respiratory Medicine, University of Toronto.
The 24-week study is beginning with enrollment in the U.S. and Canada, to be followed with international sites. Patients as young as 5 years old will be enrolled in the study.
Cystic fibrosis is a life-threatening disease that disrupts mucous production and removal from the lungs. Inspire's drug is believed to work in three areas that contribute to disease symptoms, and the treatment has been granted Fast Track status by the Food and Drug Administration.
The company's first Phase III study should report top-line efficacy results in mid-2008.
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.