- Spruce Biosciences (SPRB, Financial) acquires tralesinidase alfa for Sanfilippo Syndrome Type B (MPS IIIB).
- TA-ERT shown to normalize cerebral spinal fluid heparan sulfate levels in 5-year studies.
- Spruce plans a Biologics License Application (BLA) submission by 1H 2026.
Spruce Biosciences, Inc. (NASDAQ: SPRB), a biopharmaceutical company, has announced a strategic shift with the acquisition of tralesinidase alfa (TA-ERT), an enzyme replacement therapy for the treatment of Sanfilippo Syndrome Type B (MPS IIIB). The company plans to submit a Biologics License Application (BLA) for TA-ERT to the FDA in the first half of 2026. The enzyme replacement therapy has demonstrated the ability to significantly normalize cerebral spinal fluid heparan sulfate levels over a period of five years in clinical studies.
Regulatory progress for TA-ERT is notable, as the FDA has confirmed that the heparan sulfate non-reducing end can be used as a biomarker to predict clinical benefits, thereby supporting the potential for accelerated approval. TA-ERT has been granted fast-track, rare pediatric disease, and orphan drug designations in both the U.S. and EU, indicating a favorable regulatory pathway.
Financially, Spruce reported $38.8 million in cash and cash equivalents as of December 31, 2024, which is expected to support the company’s operations through the end of 2025. With 42.2 million shares outstanding and 21.4 million shares reserved for warrants and other equity securities, Spruce acknowledges the potential need for additional financing before the projected BLA submission.
The strategy going forward involves building a specialized commercial and medical affairs organization to maximize the U.S. commercial potential of TA-ERT for MPS IIIB. Additionally, the company seeks to establish a commercial presence in the EU and UK, and aims for strategic collaborations in other international markets.
