FDA Grants Orphan Drug Status to STX-100 - Drug Discovery and Development

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced 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.

Date: August 31, 2010
Source: Stromedix, Inc.