Lung Therapeutics Gets FDA Orphan Status For Lead Drug
Lung Therapeutics, a pharma firm specializing on niche, orphan drugs for lung disease and injury, announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate LTI-01 as treatment for empyema, a usual complication of pneumonia.
LTI-01 is an injectable, fibronolytic drug that works to maximize scar removal from the lungs and promotes fluid drainage without necessitating surgery, in addition to minimizing the risk of bleeding. LTI-01 also represents a first in class therapy for pleural effusion with loculation.
Lung Therapeutics CEO Dr. Brian Windsor, said, “Our initial focus is on LTI-01, which is designed to treat empyema and complicated parapneumonic effusions, two complications of pneumonia that can involve fibrinous scarring that inhibits fluid drainage.” The company said that LTI-01 addresses a $300+ million worldwide market.
Dr. Steven Idell, Founder and CSO of Lung Therapeutics, said, “LTI-01 could improve outcomes for thousands of patients a year who become seriously ill with pleural effusions that are difficult to drain, and increasing incidence demands more effective therapy. We believe that LTI-01 will enable patients to avoid surgical treatment and its associated morbidity and cost.”
The company revealed that it plans to progress LTI-01 into clinical trials by 2015.
The FDA’s orphan drug designation is awarded to new drugs or biologics that show potential to treat rare diseases or conditions that afflict less than 200,000 in the U.S. Should LTI-01 receive approval for its indication, Lung Therapeutics will enjoy a seven-year period of marketing exclusivity in the country, along with other benefits and incentives.
Earlier this year, the company announced that it has received grant funding to pursue early and pre-clinical development of LTI-01 as treatment for PE with loculation, along with LTI-02 for acute lung injury (ALI) and LTI-03 for idiopathic pulmonary fibrosis (IPF).