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Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
Date:6/8/2012

e over all post-baseline visits
ataluren n=116; placebo n=116

2.5%

0.0478Patients not on chronic inhaled antibiotics
ataluren n=52; placebo n=53

6.7%

0.013**nominal p-valueReduction in pulmonary exacerbation rate over 48 weeks (ITT population)Ataluren vs. PlaceboDecrease in
exacerbation ratep-valueAll patients
ataluren n=116; placebo n=116

23%

0.0992Patients not on chronic inhaled antibiotics
ataluren n=52; placebo n=53

43%

0.014**nominal p-value

The tertiary endpoints of sweat test and nasal potential difference did not show an effect between ataluren and placebo. Preliminary data from an ongoing extension study support the sustained effect of ataluren on lung function as measured by FEV1. Further analyses of these data and other study endpoints will be reported at future scientific conferences when completed.

"This is a historic time for patients with cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO, Cystic Fibrosis Foundation. "We are beginning to see the results of our commitment to the development of novel treatments for patients with cystic fibrosis. Promising therapeutic approaches that target the underlying cause of cystic fibrosis are fundamental to future therapeutic options that have the potential to change the course of the disease."

Safety results indicate that ataluren was generally well tolerated. The overall incidence of adverse events through Week 48 was similar in the ataluren and placebo groups. The most common adverse events were typical for CF and included pulmonary exacerbation, cough, and upper respiratory tract infection, which occurred at similar frequencies in the ataluren and placebo arms. Most of the serious adverse events, those requiring hospitalization, were pulmonary exacerbations unrelated to study treatment and some patients experienced creatinine elevations that occurred in connection with c
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SOURCE PTC Therapeutics, Inc.
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