Inspire broadens clinical trial for potential cystic fibrosis drug

Durham, N.C. — Inspire Pharmaceuticals (Nasdaq: ISPH) is changing the parameters of a Phase III clinical trial for a proposed cystic fibrosis drug, seeking more patients and lengthening the term of treatment.

The drug is already on fast-track toward potential approval both in the U.S. and Europe.

Following a review of early trial data, Inspire is doubling the treatment period to 48 weeks. The company also said it would work with the Cystic Fibrosis Foundation to recruit more clinical trial subjects.

The proposed drug is called denufosol tetrasodium.

In a statement, Inspire Chief Executive Officer Christy Shaffer noted that 48-week treatment meant a “more than doubled” improvement in patients.

“We are working with the participating clinical trial sites and the CF Foundation to increase awareness about [the trial] and recruit patients in order to complete the trial as quickly as possible,” Shaffer said. “We will provide periodic updates on enrollment as the trial progresses.”

The lead investigator in the trial, Felix Ratjen, a medical doctor at the University of Toronto, said “positive results” of tests thus far “have generated additional interest in denufosol in the CF medical community, which should facilitate enrollment” in the next phase of tests.

Ratjen said efficacy and safety demonstrated by denufosol thus far was “an exciting step forward.”

Cystic fibrosis affects some 40,000 people in the U.S. and 70,000 worldwide, according to the Cystic Fibrosis Foundation.