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Also known as Tralesinidase alfa (TA)
Tralesinidase alfa · 1 trial · 1 indication
The BSID-III-C is a standardized tool that evaluates cognitive development in young children, capturing skills such as processing speed, problem solving, and play. Raw scores are used to sensitively measure individual change over time, independent of age. Assessments are administered by a trained, blinded rater and reviewed by a central blinded rater. The endpoint is the difference in mean change from baseline in BSID-III-C raw score between the tralesinidase alfa and control arms at Week 260
| Arm | Type | Description |
|---|---|---|
| Tralesinidase alfa (TA) | EXPERIMENTAL | - |
| Control | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Tralesinidase alfa (TA) | DRUG | TA study drug is a sterile solution for ICV infusion. |
Inclusion Criteria: Has a diagnosis of MPS IIIB confirmed by deficient NAGLU enzyme activity during screening. Has nonattenuated severe MPS IIIB by the Genotype and Clinical Assessment Committee. Is ≥1 and ≤5 years of age with BSID-III-C raw score of \<70. Is male or female as identified at birth...
Tralesinidase alfa is an investigational drug being developed for the treatment of MPS IIIB, also known as Sanfilippo syndrome type B. It is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
Tralesinidase alfa is being developed by Spruce Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SPRB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with MPS IIIB.
Tralesinidase alfa is currently in Phase 3 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 3 trial is designed to assess the treatment's effects in participants with MPS IIIB.
Tralesinidase alfa is being studied in a Phase 3 clinical trial with the identifier NCT07579910, titled 'Intracerebroventricular Tralesinidase Alfa in Participants With MPS IIIB (Sanfilippo Syndrome Type B).' The trial is not yet recruiting and plans to enroll 14 participants.
Yes, Tralesinidase alfa is also known as Tralesinidase alfa (TA). Both names refer to the same investigational drug being developed by Spruce Biosciences for the treatment of MPS IIIB.