Spruce Biosciences develops Tralesinidase Alfa (TA-ERT), an enzyme replacement therapy that restores deficient N‑acetyl‑α‑glucosaminidase activity in the brain of patients with Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B). Using a proprietary delivery platform to cross the blood‑brain barrier, the therapy targets glycosaminoglycan accumulation to halt or reverse neurodegeneration, and is progressing toward a Biologics License Application in late 2026.
Funding
$50M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Patients with Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B) have no approved therapies, leaving them with a progressive neurodegenerative disease that leads to severe cognitive decline and early death.
Solution
Spruce Biosciences is developing Tralesinidase Alfa (TA-ERT), an enzyme replacement therapy designed to restore deficient N‑acetyl‑α‑glucosaminidase activity in the central nervous system of MPS IIIB patients. The therapy utilizes a proprietary delivery platform to cross the blood‑brain barrier and degrade accumulated glycosaminoglycans, addressing the underlying cause of the disease. Preclinical data support its potential to halt or reverse neurodegeneration, and the program has received Breakthrough, Rare Pediatric Disease, Fast Track, and Orphan Drug designations. Spruce plans to file a Biologics License Application in the fourth quarter of 2026, aiming to bring the first disease‑modifying treatment to this underserved patient population.
Target Audience
Primary customers are pediatric neurologists, metabolic disease specialists, and rare‑disease treatment centers caring for children diagnosed with MPS IIIB and their families.
Features
- Recombinant tralesinidase alfa enzyme engineered for high stability and activity in the CNS
- Delivery technology enabling efficient blood‑brain barrier penetration for systemic administration
- Clinical development pathway supported by multiple FDA expedited program designations
- Targeted degradation of glycosaminoglycans to prevent toxic accumulation in neuronal tissue
- Planned BLA submission in Q4 2026 with accelerated approval pathway eligibility