![]() TIGER-2, the second Phase 3 clinical trial with denufosol for the treatment of CF, was a 48-week, placebo-controlled, double-blind, randomized trial comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer in 466 patients with mild cystic fibrosis lung disease (baseline FEV1 greater-than or equal to 75% and less-than or equal to 110% of predicted normal).Every student should have access to a mentorship experience as a tool in their career development. The placebo-controlled portion was a double-blind, randomized trial comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in 352 patients with mild cystic fibrosis lung disease (baseline FEV1 greater-than or equal to 75% of predicted normal). TIGER-1, the first Phase 3 trial with denufosol for the treatment of CF, included a 24-week placebo-controlled portion, followed by a 24-week open-label safety extension. Inspire will be communicating with participating clinical trial sites on the next steps for the DEFY trial in the near future.Ībout the Denufosol Tetrasodium Clinical Program Based on the lack of meaningful benefit observed in TIGER-2, Inspire will be recommending that patients in the DEFY trial discontinue treatment with denufosol. Patients that completed the TIGER-2 trial were eligible to enroll in a separate three-year open-label trial of denufosol called DEFY. antibiotics for at least one respiratory sign or symptom, was similar in both treatment arms (21% for denufosol, 26% for placebo). The incidence of pulmonary exacerbations, as defined by treatment with I.V. The incidence of AEs and serious adverse events in the denufosol group was comparable to the placebo group. The most common AE was cough, which was similar in both treatment arms. Six percent of patients in both g roups withdrew from the trial due to adverse events (AEs). Patient retention rates were similar between treatment groups with approximately 82% completing the trial (82% for denufosol, 83% for placebo). antibiotics for at least one respiratory sign or symptom (p=0.132). Time to first pulmonary exacerbation, as defined by treatment with I.V.Change from baseline in FEF25%-75% (Forced Expiratory Flow) at the Week 48 Endpoint, a measure of small airways function (-0.034 L/sec for denufosol, -0.018 L/sec for placebo p=0.728) and.Rate of change in percent predicted FEV1 over 48 weeks, a measure of lung function adjusted for a patient’s predicted normal based on height, weight and gender (-2.30% for denufosol and -3.02% for placebo p=0.410). ![]() There were no statistically significant differences between denufosol and placebo for three key secondary endpoints, which were: (82%), Australia and New Zealand (11%) and Canada (6%). We want to thank the investigators, cystic fibrosis patients and caregivers for their involvement in this trial.”įor the 466 patients randomized in TIGER-2, the treatment groups were balanced with respect to demographic and background characteristics: the mean age was 15.1 years, the mean lung function was 89.7% of the predicted normal value of FEV1 and the use of concomitant medications including inhaled antibiotics, dornase alfa (PULMOZYME(R)), and oral macrolide antibiotics was similar between the treatment groups. The analysis of the primary endpoint, key secondary endpoints and select subgroup populations in TIGER-2 indicates an absence of meaningful treatment benefit in this patient population. Johnson, M.D., Executive Vice President of Research and Development and Chief Medical Officer, stated, “We believe that the TIGER-2 trial was designed and executed appropriately and was sufficient to provide data on the efficacy of denufosol at 48 weeks. Meanwhile, we will continue to focus on our ophthalmology business.”Ĭharles A. We expect to provide a detailed corporate update by mid-February. We will conduct a thorough analysis of the data to fully understand the results from this trial and the impact on any future development of denufosol and on the Company going forward. Patients receiving denufosol in the 466-patient, double-blind, placebo-controlled clinical trial had an improvement of 40 mL, compared to 32 mL for the patients receiving placebo (p=0.742).Īdrian Adams, President and CEO of Inspire, stated, “These TIGER-2 results were disappointing and unexpected given the treatment effect observed in the TIGER-1 trial. The trial did not achieve statistical significance for its primary efficacy endpoint, which was change from baseline in FEV1 (Forced Expiratory Volume in One Second) at the Week 48 Endpoint (48 weeks or last observation carried forward). announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.
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