21 August 2019 - Cerecor announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CERC-802, an ultra-pure, oral formulation of D-mannose currently in development for the treatment of Mannose-Phosphate Isomerase Deficiency, also known as MPI-CDG or CDG-1b.
CERC-802 is an ultra-pure formulation of D-mannose, a naturally occurring monosaccharide commonly found in animals, microorganisms, and plants, including edible fruits and herbs. D-mannose is consumed by the body to provide substrates for protein glycosylation, the process by which carbohydrates are utilized to modify certain proteins as it relates to protein structure and function. CERC-802 has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, making the Company eligible to receive a Priority Review Voucher (PRV) upon approval of an NDA.