Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181

An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102

AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug

Inclusion Criteria:

• Must have completed clinical trial AGT-181-102
• Voluntary written consent by patient or legally responsible representative
• All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
• Negative pregnancy test (females)

Exclusion Criteria:

• Refusal to complete screening evaluations.
• Any medical condition or other circumstances that may significantly interfere with study compliance
• Patient is pregnant or lactating
• Clinically significant spinal cord compression, evidence of cervical instability.
• Subject developed clinically relevant hypersensitivity to AGT-181