SEATTLE, Oct. 15 /PRNewswire/ -- Corus Pharma, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics to treat severe respiratory diseases, announced positive Phase II clinical trial results for its cystic fibrosis drug, Corus 1020 (Aztreonam Lysinate for Inhalation) at the North American Cystic Fibrosis conference in St. Louis.
Corus 1020 is an antibiotic that has activity against a broad spectrum of Gram-negative bacteria, including Pseudomonas aeruginosa, which commonly infect the lungs of cystic fibrosis patients. Aztreonam Lysinate for Inhalation is specifically formulated to improve airway tolerability. Inhaled delivery increases the concentration of the drug at the site of infection as compared to intravenous administration.
A Phase II study of 105 cystic fibrosis patients with Pseudomonas aeruginosa infections evaluated two dose groups (75 mg, 225 mg) taken twice daily for two weeks in a double blinded, placebo-controlled trial. Both dose levels were well tolerated with a similar adverse event profile as a placebo except that the 225 mg dose had a trend to increasing respiratory symptoms, most commonly cough, compared to either the 75 mg dose or placebo. There were no serious adverse events reported as related to Corus 1020.
There was a significant decrease in the amount of Pseudomonas aeruginosa as measured by sputum density with both dose groups showing greater than or equal to 97% reduction (greater than or equal to 1.5 log) from baseline. In patients with abnormal lung function at baseline, in both dose groups, there was overall significant improvement over the whole study in lung function as measured by percent change in FEV1. This improvement in the 75 mg dose group averaged 9% improvement from baseline, which was more consistent than seen in the patients treated with the 225 mg dose.
"We are extremely excited with the results of this trial," said A. Bruce Montgomery, MD, CEO of Corus Pharma. "We have a clear direction on the dose level and patient populations we intend to study. Pending discussions with the FDA, we expect to be able to move the program into Phase III shortly."
Corus 1020 is delivered by the eFlow(R) Electronic Nebulizer licensed from PARI GmbH with a treatment time of approximately two minutes for the 75mg dose. Current therapies utilizing jet nebulizers take approximately twenty minutes to administer a dose of aerosolized antibiotic. The study was supported in part by a grant from the Cystic Fibrosis Foundation Therapeutics, the drug discovery and development arm of the Cystic Fibrosis Foundation.
About Cystic Fibrosis
Cystic fibrosis is a genetic disease that affects approximately 30,000 children and adults in the United States and a similar number in Europe. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predisposing patients to infection, which continually damages their lungs.
About Corus Pharma:
Corus Pharma is committed to developing and commercializing products for severe respiratory and infectious diseases that can help provide improved health and superior quality of life. More information about Corus Pharma may be found at http://www.coruspharma.com/.
Corus Pharma, Inc.
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