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PTC Therapeutics Inc phase 3 trial results in Nonsense Mutation Cystic Fibrosis Published in Lancet Respiratory Medicine

Friday, 16 May 2014 08:00am EDT 

PTC Therapeutics Inc:Announced results of Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) were published in Lancet Respiratory Medicine.Results demonstrated positive trends in both primary endpoint, lung function as measured by relative change in pct predicted FEV1 and in the econdary outcome measure, rate of pulmonary exacerbations.Collective data from this trial, including retrospective and subgroup analyses support conclusion that ataluren was active and showed clinically meaningful improvements over placebo in these trials.Phase 3 double-blind, placebo-controlled study, which was conducted across 11 countries, compared ataluren (n=116) to placebo (n=116) in nmCF patients.Primary endpoint, relative change from baseline in pct-predicted FEV1at 48 weeks, showed positive trend favoring ataluren versus placebo, and larger effect in patients not receiving chronic inhaled tobramycin.In the intent-to-treat population, there was 3 pct difference in relative change from baseline in pct-predicted FEV1 between ataluren and placebo groups at Week 48 which was not statistically significant. 

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