BioTuesdays

Cerecor gets FDA fast track designation for CERC-802

Cerecor (NASDAQ:CERC) received FDA fast track designation for CERC-802 for the treatment of mannose-phosphate isomerase deficiency, also known as CDG-1b.

CDG-1b is a rare genetic disease that impacts carbohydrate metabolism, specifically protein glycosylation. CERC-802, an ultra-pure formulation of D-mannose, is designed to provide CDG-1b patients with the substrates required for normal protein glycosylation.

“We believe that the granting of fast track designation for CERC-802 is another crucial step in the development of a potential treatment for this ultra-rare condition,” Simon Pedder, executive chairman of Cerecor’s board, said in a statement.

“We continue to work closely with the FDA to advance this development program forward expeditiously. We’re currently collecting retrospective data through the CDG FIRST trial to support an NDA for a much-needed therapy,” he added.

The FDA previously granted CERC-802 orphan drug and rare pediatric disease designations, which makes Cerecor eligible to receive a priority review voucher upon NDA approval.

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