Cerecor Announces Submission of Three Orphan Drug Designation Requests for Substrate Replacement Therapies to treat Congenital Disorders of Glycosylation
Cerecor, Inc (CERC)
Last cerecor, inc earnings: 11/14 06:30 am
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Source: GlobeNewswire
BALTIMORE, Oct. 31, 2018 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) three Orphan Drug Designation (ODD) Requests for substrate replacement therapies to treat ultra-rare inherited metabolic disorders known as Congenital Disorders of Glycosylation (CDGs). Submissions were made for CERC-801, D-galactose to treat Phosphoglucomutase 1 (PGM1) Deficiency; CERC-802, D-mannose to treat Mannose-Phosphate Isomerase (MPI) Deficiency; and CERC-803, L-fucose to treat Leukocyte Adhesion Deficiency Type II (LADII). Each indication is an ultra-rare CDG estimated to have less than 1,000 patients in the United States. All three programs have been awarded Rare Pediatric Disease Designation (RPDD) by the FDA. Cerecor has already held pre-IND meetings
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