Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a respiratory disease characterized by the formation of scar tissue in the lungs called fibrosis. IPF patients exhibit a rapid increase in fibrosis leading to severe breathing difficulties, a persistent cough, and difficulty in performing daily tasks. It usually affects people between 50 and 70 years old, particularly men and smokers. The disease is fatal and approximately two-thirds of patients succumb within five years of diagnosis. Most IPF patients die of lung failure while waiting for a lung donor.
IPF is estimated to affect over 130,000 Americans. Every year, 48,000 new cases are diagnosed and 40,000 patients die from the disease. Although there are two FDA-approved therapies for IPF, Esbriet (Roche) and OFEV (Boehringer-Ingelheim), there is no cure.
AEOL 10150 in Idiopathic Pulmonary Fibrosis
Data generated in pre-clinical studies performed under the BARDA contract for Lung-ARS suggest that 10150 may prevent the development of fibrosis in diseases such as IPF. In March 2015, the Company received notice from the Office of Orphan Products Development at the U.S. Food & Drug Administration (FDA) granting Orphan Drug Designation for AEOL 10150 "for treatment of idiopathic pulmonary fibrosis." Orphan Drug Designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits.
The Company intends to file an IND for 10150 in IPF in 2015 and begin clinical studies as soon as possible.