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Denali Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to ETV:IDS (DNL310) for the Treatment of Patients with Hunter Syndrome (MPS II)
Denali Therapeutics Inc., a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome (MPS II). DNL310, Denali’s lead investigational brain-penetrant enzyme replacement therapy, is under evaluation in a Phase 1/2 study in patients with Hunter syndrome as a potential treatment for both central nervous system (CNS) and peripheral manifestations of the disease.
“Hunter syndrome is a devastating disease for which current approved treatments fail to effectively cross the blood-brain barrier and therefore do not address CNS symptoms,” said Carole Ho, M.D., Denali’s Chief Medical Officer.
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