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news.Inspire Pharmaceuticals' Denufosol tetrasodium placebo-controlled, double-blind, randomized second Phase 3 clinical trial, TIGER-2 has failed to achieve primary efficacy endpoint, evaluating cystic fibrosis (CF) patients.
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The primary endpoint of the trial was change from baseline in FEV1 (Forced Expiratory Volume in One Second) at the Week 48 Endpoint (48 weeks or last observation carried forward).
In the trial, the patients receiving Denufosol had an improvement of 40ml, compared to 32ml for the patients receiving placebo.
Patient retention rates were similar between treatment groups with approximately 82% completing the trial (82% for denufosol, 83% for placebo). 6% of patients in both groups withdrew from the trial due to adverse events (AEs).
Inspire Pharma president and CEO Adrian Adams said that these TIGER-2 results were disappointing and unexpected given the treatment effect observed in the TIGER-1 trial.
"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," Adams said.