In a recent press release, Armagen Inc. presented data from the first chorot of their Phase 1/2a sutyd of AGT-182, an investigational Enzyme Replacement Therapy that has received orphan drug designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of Hunter Syndrome aka MPS 2.
Using ArmaGen’s proprietary technology, AGT-182 is designed to take advantage of the body’s natural system for transporting products across the Blood-Brain Barrier (BBB) by binding to the same receptor that delivers insulin to the brain. AGT-182 is engineered by the fusion of the replacement IDS enzyme to an antibody that is attracted to a receptor on the BBB. The IDS enzyme is designed to travel through the BBB attached to that antibody.
To view the full press release, please click and download it below:
Armagen Press Release July 14, 2016
The favorable data from Cohort 1 informed the decision to proceed to Cohort 2, in which up to four adult (age 18 and above) patients are to receive weekly IV infusion starting at a dose of 3.0 mg/kg. If you are interested in participating in the Breaking Barriers Hunter Syndrome Trial, please sign up here.
Hunter syndrome, also known as mucopolysaccharidosis type II, or MPS 2, is a lysosomal storage disorder caused by inadequate activity of the enzyme iduronate-2-sulfate (IDS), which is needed to break down complex sugars produced in the body. Currently available treatment of Hunter Syndrome do not cross the BBB in clinically relevant amounts and therefore do not address the progressive neurological complications of the disease. Dr. James Callaway, chief executive officer of Armagen says “We are making steady progress in developing a viable therapeutic for Hunter Syndrome that crosses the BBB. Favorable data from the first cohort of patients suggests AGT-182 can safely address somatic symptoms of the disease. We are grateful for the investigators and patients who have participated in the Break Barriers trial to date, and we look forward to beginning the second cohort as recommended by the data monitoring committee in an effort to confirm these preliminary data.”