Product Description
ArmaGen was developing valanafusp alfa, an intravenous agent for patients with severe MPS I. AGT-181 is the companyÕs investigational therapy for the treatment of mucopolysaccharidosis type I (MPS I, also known as Hurler, Hurler-Scheie and Scheie syndromes). AGT_181 is a novel, investigational enzyme replacement therapy for the treatment of both somatic and cognitive symptoms in patients with MPS I. ArmaGen developed AGT-181 by re-engineering the enzyme iduronidase (IDUA) as fusion protein with an immunoglobulin G (IgG) antibody targeting the insulin receptor. Utilizing ArmaGenÕs proprietary ÒTrojan HorseÓ technology, AGT-181 takes advantage of the bodyÕs natural system for transporting proteins and other large molecules non-invasively across the blood-brain barrier (BBB), in this case by binding the same receptor that transports insulin across the BBB into the brain. (Sourced from: http://armagen.com/news/armagens-agt-181-52-week-phase-12-proof-concept-study-results-published-orphanet-journal-rare-diseases/)
Mechanisms of Action: Enzyme Replacement Therapy
Novel Mechanism: No
Modality: Fusion Protein
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: ArmaGen
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Mucopolysaccharidosis I
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AGT-181-103 | P1 |
Completed |
Mucopolysaccharidosis I |
2018-03-19 |
|
| MPS I, Hurler Syndrome | P2 |
Completed |
Mucopolysaccharidosis I |
2018-02-01 |
24% |
| AGT-181-101E | P2 |
Completed |
Mucopolysaccharidosis I |
2018-02-01 |
24% |
| MPS I, Hurler Syndrome | P1 |
Completed |
Mucopolysaccharidosis I |
2017-01-23 |
21% |