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- lepunafusp alfa (JR-171) / JCR Pharma
NEUROBEHAVIOURAL AND SOMATIC IMPROVEMENTS OBSERVED IN MPS I PATIENTS TREATED WITH LEPUNAFUSP ALFA (JR-171): REPORT OF FOUR CASES. (Poster Room | Level 0) - Jul 30, 2024 - Abstract #SSIEM2024SSIEM_470;
Along with the findings on the somatic efficacy of JR-171 in its phase 1/2 study, the observed neurobehavioural changes may suggest potential benefits of the drug on neuronopathy that requires further evaluation.
- || Aldurazyme (laronidase) / BioMarin, Sanofi, alpha-L iduronidase (JR-171) / JCR Pharma
P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: ?-L-iduronidase fused with humanized anti-human transferrin receptor antibody (lepunafusp alfa) for mucopolysaccharidosis type I: A Phase 1/2 Trial. (Pubmed Central) - Mar 11, 2024
Plasma drug concentration increased dose-dependently and reached its maximum approximately 4 hours after the end of drug administration. Decreased HS in the cerebrospinal fluid suggested successful delivery of JR-171 across the BBB, while suppressed urine and serum concentrations of the substrates indicated its somatic efficacy was comparable to that of laronidase.
- | alpha-L iduronidase (JR-171) / JCR Pharma
Preclinical, Journal: Enzyme replacement with transferrin receptor-targeted ?-L-iduronidase rescues brain pathology in mucopolysaccharidosis I mice. (Pubmed Central) - May 30, 2023
Further, no safety concerns were noted in repeat-dose toxicity studies in monkeys. This study provides nonclinical evidence that JR-171 might potentially prevent and even improve disease conditions in patients with neuronopathic MPS I without serious safety concerns.
- | lepunafusp alfa (JR-171) / JCR Pharma
Enrollment closed: An Extension Study of JR-171-101 Study in Patients With MPS I (clinicaltrials.gov) - Aug 18, 2022
P1/2, N=14, Active, not recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
This study provides nonclinical evidence that JR-171 might potentially prevent and even improve disease conditions in patients with neuronopathic MPS I without serious safety concerns. Recruiting --> Active, not recruiting
- || lepunafusp alfa (JR-171) / JCR Pharma
Trial completion: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Aug 18, 2022
P1/2, N=19, Completed, Sponsor: JCR Pharmaceuticals Co., Ltd.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | lepunafusp alfa (JR-171) / JCR Pharma
Enrollment closed: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Apr 21, 2022
P1/2, N=19, Active, not recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | lepunafusp alfa (JR-171) / JCR Pharma
Trial completion date, Trial primary completion date: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Dec 8, 2021
P1/2, N=19, Recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Recruiting --> Active, not recruiting Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: Mar 2022 --> Jun 2022
- || lepunafusp alfa (JR-171) / JCR Pharma
Enrollment open: An Extension Study of JR-171-101 Study in Patients With MPS I (clinicaltrials.gov) - Oct 11, 2021
P1/2, N=15, Recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: Mar 2022 --> Jun 2022 Not yet recruiting --> Recruiting
- | lepunafusp alfa (JR-171) / JCR Pharma
Trial primary completion date: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Sep 17, 2021
P1/2, N=19, Recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Not yet recruiting --> Recruiting Trial primary completion date: Sep 2021 --> Mar 2022
- | lepunafusp alfa (JR-171) / JCR Pharma
Trial completion date, Trial initiation date, Trial primary completion date: An Extension Study of JR-171-101 Study in Patients With MPS I (clinicaltrials.gov) - Apr 27, 2021
P1/2, N=15, Not yet recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Trial primary completion date: Sep 2021 --> Mar 2022 Trial completion date: Oct 2026 --> Apr 2025 | Initiation date: May 2021 --> Oct 2021 | Trial primary completion date: Oct 2026 --> Apr 2025
- || lepunafusp alfa (JR-171) / JCR Pharma
Enrollment open, Trial completion date: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Feb 10, 2021
P1/2, N=19, Recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
Trial completion date: Oct 2026 --> Apr 2025 | Initiation date: May 2021 --> Oct 2021 | Trial primary completion date: Oct 2026 --> Apr 2025 Not yet recruiting --> Recruiting | Trial completion date: Sep 2021 --> May 2022
- || lepunafusp alfa (JR-171) / JCR Pharma
New P1/2 trial: An Extension Study of JR-171-101 Study in Patients With MPS I (clinicaltrials.gov) - Jun 30, 2020
P1/2, N=15, Not yet recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.
- || lepunafusp alfa (JR-171) / JCR Pharma
New P1/2 trial: A Study of JR-171 in Patients With Mucopolysaccharidosis I (clinicaltrials.gov) - Jan 12, 2020
P1/2, N=18, Not yet recruiting, Sponsor: JCR Pharmaceuticals Co., Ltd.