Company to Evaluate Orphan Diseases as Secondary Indications
BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – July 28, 2013) BioAegis Therapeutics announced that the FDA has transferred Orphan Designations for cystic fibrosis and bronchiectasis to the company. The FDA Office of Orphan Products Development (OOPD) provides support and incentives for sponsors to develop products for rare diseases. For example, The OOPD administers extramural grant programs such as The Orphan Products Clinical Trials Grants Program which provides funding for clinical research. Cystic fibrosis is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States and an additional 70,000 worldwide. Bronchiectasis is a chronic condition where the walls of the bronchi are thickened from inflammation and infection with approximately 110,000 known cases in the US.