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iBio, Inc. a leading provider of plant-based biotechnology for developing and manufacturing biological products, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to iBio's investigational biotherapeutic product, iBio-CFB03, for the treatment of systemic sclerosis.
Systemic sclerosis is a fibrotic disorder that affects connective tissue of skin and internal organs as well as the walls of blood vessels. Early diagnosis and individualized therapy can be helpful, but treatment of systemic sclerosis is limited to symptom management. No approved drug currently available has been shown to arrest the underlying process or processes that drive progression of the disease.
"This is an important step toward our goal for a family of iBio proprietary products against fibrotic diseases like systemic sclerosis and idiopathic pulmonary fibrosis," said Robert B. Kay, iBio's Executive Chairman. "We expect to apply for additional Orphan Drug Designations for products against additional fibrotic diseases. Viewed together and across the major geographic markets, effective therapies against fibrotic diseases are among the most significant unmet medical needs in the world."
Development of iBio-CFB03 as an anti-fibrotic agent is based on the involvement of endostatin in fibrotic disease, identification of endostatin's anti-fibrotic activity residing in the C-terminal region on which the design of iBio-CFB03 is based, and the efficacy of endostatin, its C-terminal peptides, and iBio-CFB03 in experimental models of fibrosis.
