Gilead Sciences Inc. said on Friday that its Aztreonam lysine treatment for cystic fibrosis met positive results in a Phase III clinical study designed to determine the safety and efficacy of the drug.
The company revealed its inhaled drug met safety goals at the Annual European Cystic Fibrosis Conference in Czech Republic today.
The steadily increasing life expectancy of Cystic Fibrosis patients and the chronic nature of this infection underscore the importance of long-term safety and efficacy data for potential new respiratory therapies, said Dr. Christopher M. Oermann, MD, Associate Professor of Pediatrics, Director, Pediatric Pulmonary Fellowship Training Program, Baylor College of Medicine in a statement.
Aztreonam lysine for inhalation use is an antibiotic candidate currently evaluated with people with cystic fibrosis who have pulmonary P. aeruginosa. Gilead reported the drug is formulated with the agent arginine already approved by the U.S. Food and Drug Administration.
More than 70,000 people in the world suffer from cystic fibrosis, a chronic and debilitating genetic disease, according to Gilead. The company is currently treating 111 patients with aztreonam lysine treatment and is expected to complete the late stage study by the fourth quarter of 2008.
Gilead submitted its U.S. New Drug Application for aztreonam lysine for inhalation to the Food and Drug Administration on November 16, 2007. The FDA has established a target review date, under the Prescription Drug User Fee Act, of September 16, 2008.
Shares of Gilead Sciences Inc. rose 2.86 percent to $54.23 in Nasdaq morning trade on Friday.