CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung. There are currently no FDA approved treatments for IPF. Stromedix is planning to initiate a Phase 2 clinical trial in IPF patients in 2011.
“STX-100 targets a key pathway in the initiation and progression of pulmonary fibrosis and therefore may ultimately become a much needed treatment option for IPF patients,” said Michael Gilman, Ph.D., CEO of Stromedix. “We are very excited about the potential of this compound and look forward to initiating a Phase 2 clinical trial of STX-100 in IPF patients in 2011.”
Orphan drug designation is granted by the FDA to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the designation, the FDA may provide grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following drug approval by the FDA. For more information about orphan designation, please visit the FDA website at http://www.fda.gov.
STX-100 is a novel, investigational, humanized monoclonal antibody that targets integrin αvβ6. STX-100 exhibits significant anti-fibrotic activity in preclinical animal models of kidney, lung and liver disease. Stromedix has completed a Phase 1 clinical trial of STX-100 and is currently planning Phase 2 trials in idiopathic pulmonary fibrosis and chronic allograft nephropathy, a condition that leads to graft failure in kidney transplant patients. The FDA has previously granted orphan drug designation to STX-100 for chronic allograft nephropathy. Stromedix believes that STX-100 has broad potential therapeutic utility in chronic organ failure, acute organ failure and cancer.
About Idiopathic Pulmonary Fibrosis (IPF)
According to the National Institutes for Health (NIH), IPF is a condition in which the lung tissue becomes thickened, stiff, and scarred. This scar tissue is called fibrosis. As fibrosis accumulates, the lungs lose their ability to transfer oxygen into the bloodstream. IPF affects approximately 115,000 Americans and an estimated 40,000 Americans die from IPF each year.
Stromedix is a privately held biotechnology company based in Cambridge, Massachusetts, focused on innovative therapies for fibrotic organ failure. Investors in Stromedix include Atlas Venture, New Leaf Venture Partners, Frazier Healthcare Ventures, Bessemer Venture Partners and Red Abbey Venture Partners. Biogen Idec is also a shareholder. For more information on Stromedix, please visit http://www.stromedix.com.
Michael Gilman, Ph.D., (617) 674 8402
Chief Executive Officer
Suda Communications LLC
Paul Kidwell, 617-296-3854
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical FDA