Inspire's denufusol to enter Ph III in USA

The USA's Inspire Pharmaceuticals plans to initiate a Phase III program to advance its drug candidate denufosol tetrasodium for the treatment of cystic fibrosis, following yjr successful completion of an end-of-Phase II meeting with the Food and Drug Administration.

The focus of the program will be to develop the agent as an early intervention therapy for treatment of patients with mild lung disease.

The firm plans to conduct two pivotal Phase III clinical trials in CF patients with forced expiratory volume over one second as the primary endpoint. The first will be a pivotal efficacy trial that will also fulfill the requirement to study denufosol in patients for one year. Initiation of this trial is targeted to begin mid-year. A single two-year inhalation carcinogenicity study in one species is expected to be initiated before the end of 2006, following the FDA's review of the toxicology protocol, the firm noted.