Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.
The poster, “Pharmacological Treatment of CF: Lessons Learned from a Phase 3 Clinical Trial” (T. Navratil, A. Schaberg, D. Mathews, C. Deans, T. Durham, F.J. Accurso), will be presented in Exhibit Hall B during the formal poster sessions on Thursday, October 15 from 11:50 am - 1:50 pm and Friday, October 16 from 7:00 am - 8:30 am local time. The poster describes the treatment regimen for a young, relatively mild patient population using a sample of 175 CF patients who were assigned to placebo in TIGER-1, Inspire’s first Phase 3 clinical trial with denufosol.
“This analysis highlights the use of numerous medications that treat the respiratory conditions resulting from CF. These important findings underscore the need for early intervention disease-modifying therapies that may reduce the need for multiple pharmacological treatments,” stated Frank J. Accurso, M.D., Head of Pulmonary Medicine, Director of Cystic Fibrosis Center at University of Colorado, Denver, and the lead principal investigator for TIGER-1.
The poster presentation will be available on Inspire’s website, www.inspirepharm.com, following the conference.
The Company also announced today 430 out of the targeted 450 patients have been enrolled in its second Phase 3 clinical trial with denufosol for the treatment of CF, TIGER-2. This trial is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of 60 mg of denufosol versus placebo, administered three-times daily by jet nebulizer for 48 weeks in patients with FEV1 (Forced Expiratory Volume in One Second) greater than or equal to 75% and less than or equal to 110% predicted normal. Inspire continues to expect enrollment in TIGER-2 to be complete by the end of the year.
Throughout the development of denufosol, Inspire has worked closely with the Cystic Fibrosis Foundation (CFF) and its Therapeutics Development Network (TDN), a nationwide network of nearly 80 CF clinical research centers, and the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), a non-profit drug discovery and development affiliate. The CFF and its affiliates have provided information used in planning the denufosol development program, raised awareness about the need for patients to participate in clinical trials, and provided Inspire financial support for a key Phase 2 clinical trial.