Fast Track Designation for EDI200 for X-linked Hypohidrotic Ectodermal Dysplasia

Edimer Pharmaceuticals announced the receipt of Fast Track designation from the FDA for EDI200 for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED). XLHED is a rare orphan disease that causes a range of symptoms including lack of sweat glands, poor temperature control, respiratory problems, and hair and tooth malformations.

EDI200 has demonstrated substantial and durable efficacy in mouse and dog models of XLHED with notable reduction in mortality and morbidity.

EDI200 is an ectodysplasin-A (EDA-A1) replacement protein, representing the first of a new class of molecules rationally designed to correct a specific developmental disorder. EDI200 has been shown to bind specifically to the EDA-A1 receptor, activating the signaling pathways that lead to normal development.

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