Ongoing Trial: AGT-182 Phase 1 Trial in Hunter Syndrome
The purpose of this Phase 1 clinical trial is to test the safety and determine a well-tolerated dose of the investigational treatment AGT-182 for male patients (age 18 years and older) with Hunter syndrome or mucopolysaccharidosis type II (MPS II).
Patients in the trial will receive weekly infusions of AGT-182 at assigned doses that range from 1 mg/kg for the first dose group of patients enrolled and increase to 3.0 mg/kg. Additional higher dose levels may be added. AGT-182 will be administered intravenously over a 3-hour period for eight weeks.
ArmaGen’s former CEO and the company’s former VP, Clinical Affairs discuss the AGT-182 Phase 1 clinical trial for Hunter syndrome.
Video by Emory University featuring first patient dosed in AGT-182 trial. Comments and opinions are not necessarily endorsed by ArmaGen.
Ongoing Trial: AGT-181 Phase 2 Trial in MPS I
ArmaGen is conducting a Phase 2 proof-of-concept clinical trial treating pediatric patients with Hurler syndrome in Brazil. The study is an open-label, multi-dose, dose-escalation study in children (age two or older) with Hurler or Hurler-Scheie syndrome and central nervous system involvement.
The primary objective of this study is to determine the safety and tolerability of weekly infusions of 1.0 or 3.0 mg/kg of AGT-181. Ten patients will be enrolled into the study and the period of observation will be six months. Patients for whom it can be demonstrated that a cognitive benefit was achieved will be offered an open label 12-month extension treatment protocol to collect additional long-term safety and efficacy data.