Drugs / SOBI003
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03811028 | Jan 2019 → Apr 2021 | mucopolysaccharidosis type 3A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Phase 1/2 | NCT03423186 | Jun 2018 → Oct 2019 | mucopolysaccharidosis type 3A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-01-23 | Sobi, Inc. | Regulatory FDA accepts investigational new drug application and grants Fast Track status for SOBI003 for the treatment of MPS IIIA sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. |
| 2017-07-05 | Sobi, Inc. | Regulatory FDA grants SOBI003 Orphan Drug Designation for the treatment of MPS IIIA sobi.com ↗ |
| 2016-10-19 | Sobi, Inc. | Regulatory European Commission grants SOBI003 orphan designation for the treatment of MPS IIIA sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-08-10 | Sobi, Inc. | First patient dosed in phase 1/2 study evaluating SOBI003 for treatment of mucopolysaccharidosis type IIIA (MPS IIIA) sobi.com ↗ |
| 2018-01-23 | Sobi, Inc. | FDA accepts investigational new drug application and grants Fast Track status for SOBI003 for the treatment of MPS IIIA sobi.com ↗ |
| 2017-07-05 | Sobi, Inc. | FDA grants SOBI003 Orphan Drug Designation for the treatment of MPS IIIA sobi.com ↗ |
| 2016-10-19 | Sobi, Inc. | European Commission grants SOBI003 orphan designation for the treatment of MPS IIIA sobi.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SOBI003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03423186 ↗ |
| Known as | Chemically modified recombinant human sulfamidase | “Chemically modified recombinant human sulfamidase (SOBI003) in mucopolysaccharidosis IIIA patients: Results from an open, non-controlled, multicenter study.” PMID 35835061 ↗ Jun 2022 |
| Modality | Protein / enzyme biologic | “a chemically modified recombinant human (rh) Sulfamidase” NCT03423186 ↗ |
| Route | Intravenous | “weekly intravenous injections of SOBI003 at 3 mg/kg (Cohort 1, n = 3) or 10 mg/kg (Cohort 2, n = 3)” PMID 35835061 ↗ Jun 2022 |