Inspire Pharmaceuticals (Nasdaq: ISPH) has entered a collaboration with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), a non-profit drug development affiliate of the Cystic Fibrosis Foundation, that will provide funding of a Phase II study for the treatment of cystic fibrosis (CF).

The Phase II study is being conducted based on results from a recently completed Phase I/II study, Inspire says. In addition, Inspire says it has received Fast Track designation from the FDA for INS37217 Respiratory for the treatment of CF.

The CFFT has agreed to provide the majority of funding of external costs for a Phase II trial of INS37217 Respiratory in exchange for
post-commercialization milestone payments to be made following FDA approval. Financial terms of the agreement were not disclosed.

This trial, which has been designed in collaboration with the CFFT, will be a 28-day, double-blind, placebo-controlled, parallel group study of INS37217 Respiratory inhaled solution. The study will be conducted in approximately 90 patients with mild CF lung disease at 12 U.S. sites.

Inspire says it will work closely with the Cystic Fibrosis Therapeutics Development Network (CF TDN) and Coordinating Center in conducting the Phase II study. It is targeted for initiation by the end of 2002.

“We are pleased with the momentum in this program,” stated Christy Shaffer, chief executive officer of Inspire, said in a statement. “It is particularly exciting for us to see encouraging results in our CF program?. We have had productive interactions with the CFFT and the CF TDN over the past year, and are looking forward to strengthening these relationships further through this collaboration as we continue the development of a novel and valuable
potential product for this life-threatening disease.”

Inspire Pharmaceuticals:

Cystic Fibrosis Foundation: