Inspire to start phase 3 cystic fibrosis trial following successful phase 2 data

By Elaine Rigoli

Tampa, Fla., June 16 - Inspire Pharmaceuticals, Inc. said it will begin a phase 3 program later this year to test denufosol tetrasodium as an early intervention therapy for the treatment of cystic fibrosis (CF) patients with mild lung disease.

The decision to move forward with the phase 3 program followed the release of positive data from two phase 2 trials in CF patients with mild-to-moderate lung disease.

The two 28-day, placebo-controlled, randomized multi-center trials enrolled 161 CF patients and focused on the effects of denufosol tetrasodium on lung function and exacerbation rates in CF patients with mild-to-moderate lung function impairment.

The company said doses of denufosol up to 60 mg given three times daily were generally well-tolerated.

Although these studies were not designed as efficacy studies, denufosol had favorable effects on lung function and exacerbation rates over 28 days in patients with mild lung function impairment.

Denufosol tetrasodium is a selective P2Y2 agonist designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms.

Inspire is a biopharmaceutical company located in Durham, N.C.

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