Stromedix lung disease drug gets boost from FDA
Stromedix Inc. has received word from the U.S. Food and Drug Administration that its potential drug to treat a fatal lung disease will receive orphan drug status.
Orphan drug status is designed to accelerate development of treatments for rare diseases. The designation carries several benefits for the company, including grants and/or tax incentives to help with drug development and a longer period of protection from generic competition once the drug candidate is approved.
The drug candidate, called STX-100, is a potential treatment for idiopathic pulmonary fibrosis, a disease in which patients experience progressive difficulty breathing due to scarring of the lung. The disease is usually fatal, according to the company, and affects approximately 115,000 patients in the United States. There are currently no FDA-approved treatments for the disease. Cambridge-based Stromedix is planning to launch a Phase 2 trial for STX-100 next year.
Investors in privately-held Stromedix include Atlas Venture, New Leaf Venture Partners, Frazier Healthcare Ventures, Bessemer Venture Partners and Red Abbey Venture Partners. Cambridge-based Biogen Idec is also a shareholder.