Spruce Biosciences Acquires TA-ERT For Sanfilippo Syndrome Type B Treatment

(RTTNews) - Spruce Biosciences, Inc. (SPRB), Tuesday announced the acquisition of tralesinidase alfa enzyme replacement therapy or TA-ERT for the treatment of Sanfilippo Syndrome Type B or MPS IIIB, a neurodegenerative and fatal genetic disease.

The company stated that TA-ERT has significantly and durably normalized cerebral spinal fluid heparan sulfate non-reducing end levels in clinical trials over a five-year period.

Further, the U.S. Food and Drug Administration stated that HS-NRE could be used as a biomarker that may reasonably predict clinical benefit and serve as a basis for accelerated approval.

Based on the encouraging data, Spruce plans to submit a Biologics License Application Submission to FDA for TA-ERT in the first half of 2026.

Looking ahead, Spruce intends to seek U.S. accelerated approval of TA-ERT for MPS IIIB based on existing non-clinical and clinical data.

Moreover, the company seeks to commercialize TA-ERT and its other investigational products throughout the international markets, including North America, the European Union, the United Kingdom, Latin America, Turkey, and Asia.

Notably, TA-ERT has received fast-track designation, rare pediatric disease designation, and orphan drug designation in the U.S. and EU.

As of December 31, 2024, Spruce had cash and cash equivalents of $38.8 million. The company expects its cash runway to fund its current operating plan through the end of 2025.

In the pre-market hours, Spruce's stock is trading at $0.26, down 17.72 percent on the Nasdaq.