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Phase 2 Trial Initiated To Evaluate Denufosol Tetrasodium as a Potential Treatment for Cystic Fibrosis
This study is a double-blind, randomized comparison of two doses of INS37217 Respiratory to placebo in 72 patients with CF at 17 clinical centers across the United States. INS37217 Respiratory or placebo will be administered three times daily for 28 days by standard jet nebulizer.
This second Phase 2 trial is being conducted in order to gain a greater understanding of safety and tolerability of INS37217 Respiratory in a broader population of CF patients, which may allow expansion of the patient population for the upcoming Phase 3 trial. This broader study population will include patients using antibiotics and other therapeutics currently used by CF patients and the study will also include patients with lower lung function (FEV1 as low as 60%).
In addition, Inspire recently began two longer-term inhalation toxicology studies in preparation for future Phase 3 clinical development. These required toxicology studies will be conducted in parallel with the newly initiated Phase 2 trial.
"We continue to be very excited about Inspire's potential breakthrough product for CF and believe that results from this additional Phase 2 trial will provide us with useful information for designing our Phase 3 program for this promising drug," stated Christy L. Shaffer, Ph.D., CEO of Inspire. "Our program remains on schedule, with a goal of completing ongoing studies and finalizing plans with the FDA for our Phase 3 program before the end of 2005."
A manuscript based on results from the Phase 1/2 clinical trial of INS37217 Respiratory has been accepted by Pediatric Pulmonology for publication in 2005. Posters related to Inspire's Phase 2 trial, which were presented at the 2004 North American Cystic Fibrosis Conference in October, are currently available on Inspire's website, www.inspirepharm.com, in the Discovery & Development section, under Science & Technology.
Source: Inspire Pharmaceuticals, Inc