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|  |  Inspire Provides Update on Cystic Fibrosis Program; Moving Forward to Request End-of-Phase 2 Meeting with FDAPress Release October 13, 2005 DURHAM, N.C.--(BUSINESS WIRE)--Oct. 13, 2005--Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) today announced that three studies in its cystic fibrosis (CF) program, including two six-month animal toxicology s tudies and a Phase 2 safety trial of denufosol tetrasodium (Trial 08-104) in 72 CF patients, have been completed. Plans are underway to submit these results to the U.S. Food and Drug Administration (FDA) and request an End-of-Phase 2 meeting. The animal inhalation toxicology studies, which were required by the FDA to move into Phase 3 development with denufosol, included a six-month dog study and a six-month rat study. Based on review of the results of these toxicology studies by Inspire and its consulting toxicologists, the Company believes that the safety profile of denufosol is acceptable for advancement into Phase 3 clinical trials. The purpose of Trial 08-104 was to gain a greater understanding of the safety and tolerability of denufosol in a different population of CF patients than those enrolled in Trial 08-103, for which positive results were reported in April 2004. In contrast to Trial 08-103, Trial 08-104 enrolled patients with lower lung function and patients using concomitant medications, including oral and inhaled antibiotics. Both Trials 08-103 and 08-104 included patients using PULMOZYME(R) (dornase alfa). Trial 08-104 was not designed or powered to demonstrate statistically significant differences between denufosol and placebo with respect to efficacy, and no statistically significant differences were observed. Trial 08-104 was a double-blind, randomized comparison of two doses of denufosol (20 mg and 60 mg) to placebo administered three times daily for 28 days by standard jet nebulizer in CF patients at 17 clinical centers across the United States. The mean age of subjects randomized in the trial was 21 years old (versus 16 years old in Trial 08-103). Lung function in both Phase 2 trials was primarily measured by FEV1 (Forced Expiratory Volume over one second). The mean lung function at baseline was 75% of the predicted normal value (versus 93% in Trial 08-103). Of the 72 patients randomized, 88% completed Trial 08-104. Two serious adverse events were reported in Trial 08-104. Both events were pulmonary exacerbations following the treatment phase, one on placebo and one on the 60 mg dose. As in previous trials, the most common adverse event was cough, which occurred in 40% of subjects overall and was comparable across all groups, including placebo. The 20 mg dose was generally well tolerated across all patients enrolled in Trial 08-104. As observed in previous trials, both the 20 mg and 60 mg doses of denufosol were generally well tolerated in the patient population with milder disease (FEV1 of 75-90%). Patients with lower lung function (FEV1 of 60-74%) reported more respiratory adverse events across all treatment groups compared to patients with milder disease. Some of these events were acute transient declines in lung function following initial dosing that led to trial withdrawals, in particular in the 60 mg group. These observations are consistent with the expected pharmacologic activity of denufosol in enhancing airway hydration and mucociliary clearance. In the subset of patients using PULMOZYME(R) in Trial 08-104, positive trends in efficacy were observed when compared to placebo, similar to Trial 08-103. These trends were not statistically significant in either trial. In patients using other concomitant medications, including oral antibiotics and inhaled tobramycin, detailed analysis of Trial 08-104 results is ongoing. The interpretation of results for patients on inhaled tobramycin is complex, due to the small size of the trial and the logistics of intermittent inhaled tobramycin treatment (generally one month on; one month off).
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