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Cystic fibrosis drug disappoints in trial

Shares of Inspire Pharma have fallen by 58 per cent after its cystic fibrosis drug denufosol tetrasodium failed to meet expectations in a phase III trial

Shares of Inspire Pharma have fallen by 58 per cent after its cystic fibrosis drug denufosol tetrasodium failed to meet expectations in a phase III trial.

The drop in value to $3.49 per share is a two-year low for the US-based company, and follows the announcement of top-line results from the TIGER-2 clinical trial.

The trial involved 466 patients and investigated the efficacy and safety of denufosol compared to placebo. It was found that there was no statistical significance for the trial's primary efficacy endpoint of improved lung function after 48 weeks.

No significant difference between denufosol and placebo were reported for three key secondary endpoints either.

"These TIGER-2 results were disappointing and unexpected given the treatment effect observed in the TIGER-1 trial,” said Adrian Adams, president and CEO of Inspire. "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."

Inspire has further advised patients taking denufosol as part of the separate DEFY trial to discontinue treatment with the product due to a 'lack of meaningful benefit'.

The company will issue further guidance regarding the DEFY trial in the near future.

4th January 2011

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