The focus of the proposed phase III program will be to develop denufosol for cystic fibrosis (CF) as an early intervention therapy for treatment of patients with mild lung disease.
Based on the end-of-phase II meeting with the FDA, Inspire plans to conduct two pivotal phase III clinical trials in CF patients with “forced expiratory volume over one second” (FEV1) as the primary endpoint.
Inspire has conducted six studies in support of the denufosol CF program, involving more than 300 patients and volunteers.
“There is tremendous excitement in the CF community for a potential early intervention therapy, such as denufosol,” commented Dr Robert Beall, president and CEO of the Cystic Fibrosis Foundation.