- |||||||||| Izcargo (pabinafusp alfa) / JCR Pharma, Takeda
Trial completion date, Trial primary completion date: A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - Jun 5, 2023
P3, N=80, Recruiting,
Trial completion date: Oct 2026 --> Jan 2026 | Trial primary completion date: Oct 2026 --> Jan 2026 Trial completion date: Jan 2026 --> Oct 2026 | Trial primary completion date: Jan 2026 --> Oct 2026
- |||||||||| Izcargo (pabinafusp alfa) / JCR Pharma, Takeda
Trial completion date, Trial primary completion date: A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - Jul 7, 2022
P3, N=80, Recruiting,
Trial completion date: Jan 2026 --> Oct 2026 | Trial primary completion date: Jan 2026 --> Oct 2026 Trial completion date: Aug 2024 --> Jan 2026 | Trial primary completion date: Aug 2024 --> Jan 2026
- |||||||||| recombinant-iduronate-2-sulfatase (JR-032) / GSK, JCR Pharma, idursulfase (JR-141) / JCR Pharma
Preclinical, Journal: Clearance of heparan sulfate in the brain prevents neurodegeneration and neurocognitive impairment in MPS II mice. (Pubmed Central) - Dec 16, 2021
Furthermore, HS concentrations in the brain and reduction thereof by pabinafusp alpha correlated with those in the cerebrospinal fluid (CSF). Thus, repeated intravenous administration of pabinafusp alfa to MPS II mice decreased HS deposition in the brain, leading to prevention of neurodegeneration and maintenance of neurocognitive function, which may be predicted from HS concentrations in CSF.
- |||||||||| recombinant-iduronate-2-sulfatase (JR-032) / GSK, JCR Pharma, idursulfase (JR-141) / JCR Pharma
P2/3 data, Journal: A Phase 2/3 Trial of Pabinafusp Alfa, IDS Fused with Anti-Human Transferrin Receptor Antibody, Targeting Neurodegeneration in MPS-II. (Pubmed Central) - Oct 22, 2021
Pabinafusp alfa (JR-141) is a novel enzyme drug that crosses the blood-brain barrier by transcytosis via transferrin receptors...Drug-related adverse events were mild or moderate in severity, transient, and manageable. The results establish delivery across the BBB of pabinafusp alfa as an effective therapeutic for treating both the CNS and peripheral symptoms of patients with MPS-II.
- |||||||||| Izcargo (pabinafusp alfa) / JCR Pharma, Takeda
Trial completion date, Trial initiation date, Trial primary completion date: A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - Aug 18, 2021
P3, N=50, Not yet recruiting,
The results establish delivery across the BBB of pabinafusp alfa as an effective therapeutic for treating both the CNS and peripheral symptoms of patients with MPS-II. Trial completion date: Mar 2024 --> Aug 2024 | Initiation date: Mar 2021 --> Aug 2021 | Trial primary completion date: Mar 2024 --> Aug 2024
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