AGT-182 Designated Orphan Drug for Rare Genetic Disorder

Armagen announced that the FDA has granted Orphan Drug Designation to its lead product AGT-182 for the treatment of mucopolysaccharidosis type II, also known as Hunter syndrome or MPS II. AGT-182 is a human insulin receptor monoclonal antibody-fused iduronate 2-sulfate designed to cross the blood brain barrier (BBB) through the insulin receptors present on the BBB.

Hunter syndrome, or mucopolysaccharidosis type II (MPS II), is a serious genetic disorder that primarily affects males (X-linked recessive). It interferes with the body’s ability to break down and recycle specific mucopolysaccharides, also known as glycosaminoglycans (GAG).

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