SOBI003
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July 15, 2022
Chemically modified recombinant human sulfamidase (SOBI003) in mucopolysaccharidosis IIIA patients: Results from an open, non-controlled, multicenter study.
(PubMed, Mol Genet Metab)
- P1/2 | "SOBI003 was well tolerated when administered as weekly intravenous infusions at doses of up to 20 mg/kg for up to 104 weeks. ADA development was common and likely affected both PK and PD parameters. SOBI003 crossed the BBB and showed pharmacological activity on HS in CSF."
Clinical • Journal • CNS Disorders • Lysosomal Storage Diseases • Metabolic Disorders • Rare Diseases
June 02, 2021
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=6; Completed; Sponsor: Swedish Orphan Biovitrum; Active, not recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ May 2021; Trial primary completion date: Dec 2021 ➔ Apr 2021
Clinical • Trial completion • Trial completion date • Trial primary completion date • Lysosomal Storage Diseases • Pediatrics
April 02, 2020
A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=6; Completed; Sponsor: Swedish Orphan Biovitrum; Active, not recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Oct 2019; Trial primary completion date: Feb 2020 ➔ Oct 2019
Clinical • Trial completion • Trial completion date • Trial primary completion date
February 19, 2020
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=9; Active, not recruiting; Sponsor: Swedish Orphan Biovitrum; Recruiting ➔ Active, not recruiting
Enrollment closed
February 19, 2020
A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=9; Active, not recruiting; Sponsor: Swedish Orphan Biovitrum; Recruiting ➔ Active, not recruiting
Clinical • Enrollment closed
January 28, 2019
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=9; Recruiting; Sponsor: Swedish Orphan Biovitrum; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open
January 22, 2019
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
(clinicaltrials.gov)
- P1/2; N=9; Not yet recruiting; Sponsor: Swedish Orphan Biovitrum
Clinical • New P1/2 trial
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