Inspire Pharmaceuticals ($ISPH) started the biotech year with a bang as its share price exploded on the news that its cystic fibrosis drug denufosol failed the second of two Phase III clinical trials. Investigators in the trial tracked a measure of lung function--FEV1, or forced expiratory volume in one second. But the company's lead therapy failed to hit the primary endpoint as well as three secondary endpoints, falling short of statistically significant responses when compared to a placebo.
"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," concluded Charles A. Johnson, M.D., head of R&D at Raleigh, NC-based Inspire. Investigators recruited 466 patients for the study. Its shares tanked 48 percent on the news.
"These TIGER-2 results were disappointing and unexpected given the treatment effect observed in the TIGER-1 trial," said CEO Adrian Adams. "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. We expect to provide a detailed corporate update by mid-February. Meanwhile, we will continue to focus on our ophthalmology business."
- here's the Inspire release