Inspire continues to enroll cystic fibrosis patients in denufosol tetrasodium phase 3 clinical trial

By Jennifer Lanning Drey

Eugene, Ore., Sept. 8 - Inspire Pharmaceuticals, Inc. continues to enroll patients in the first of two phase 3 clinical trials evaluating its drug candidate, denufosol tetrasodium Inhalation Solution, for mild cystic fibrosis lung disease, according to Christy L. Shaffer, chief executive officer of Inspire.

The company also is preparing for a second pivotal clinical trial of the drug that has not yet been initiated, Shaffer told investors at the Thomas Weisel health care conference on Friday.

Inspire is referring to the studies as Tiger 1 and Tiger 2, respectively.

The Tiger 1 trial is designed to include a 24-week efficacy treatment period followed by a 24-week safety extension period.

The Food and Drug Administration has also told Inspire that it must perform a two-year inhalation carcinogenicity study of the drug in rats prior to its approval, she said.

If approved, the drug will be used to treat patients with early forms of cystic fibrosis, Shaffer said.

In addition, Shaffer said Friday that Inspire remains on track to begin a phase 2 clinical trial of intranasal epinastine for the treatment of seasonal allergic rhinitis by the end of the year.

The company estimates the drug would have a $2.8 billion annual market opportunity if approved.

Inspire also is considering a series of compounds in preclinical studies that could be used to treat glaucoma, which is the leading cause of preventable blindness in the United States.

Inspire is a biopharmaceutical company located in Durham, N.C.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.