Based on results so far in Phase II tests, Inspire Pharmaceuticals is preparing to ask the Food and Drug Administration to begin a new round of tests for its proposed cystic fibrosis drug.
Inspire has completed two sixth-month toxicology tests with animals and a Phase II trial involving 72 humans with cystic fibrosis. The drug is called denufosol tetrasodium.
“Based on review of the (animal) results of these toxicology studies by Inspire and its consulting toxicologists, the Company believes that the safety profile of denufosol is acceptable for advancement into Phase 3 clinical trials,” Inspire said. The human trial was designed to test safety and tolerability.