Spruce Biosciences Unveils New Strategy and Acquires Tralesinidase Alfa for MPS IIIB Treatment

Spruce Biosciences, Inc., a leading biopharmaceutical company based in South San Francisco, has announced a significant shift in its corporate strategy, marked by the acquisition of a promising enzyme replacement therapy known as tralesinidase alfa (TA-ERT). This new therapy is specifically targeted at treating Sanfilippo Syndrome Type B (MPS IIIB), a rare and fatal neurological disorder that currently lacks FDA-approved treatment options.

Under the leadership of CEO Dr. Javier Szwarcberg, Spruce Biosciences is poised to transform its focus towards the treatment of rare diseases. The acquisition of TA-ERT is seen as a pivotal move to address the unmet medical needs of children suffering from MPS IIIB. Dr. Szwarcberg expressed optimism about the potential of TA-ERT, highlighting its success in clinical studies where it effectively normalized specific biomarkers over an extended period.

A major milestone in the development of TA-ERT is the alignment with the U.S. Food and Drug Administration (FDA) regarding the biomarkers that could predict the therapy's clinical benefits. This alignment sets the stage for an accelerated approval process, which Spruce Biosciences aims to initiate by submitting a Biologics License Application (BLA) in the first half of 2026.

Mike Grey, Executive Chairman of Spruce, emphasized the company’s commitment to addressing the significant gaps in treatment for rare conditions. He noted the Board's strong support for the new strategic direction, which highlights the potential for TA-ERT to make a meaningful impact on the lives of patients and their families.

Spruce’s corporate strategy is centered around obtaining regulatory approval and maximizing the commercial potential of TA-ERT in the U.S. The company plans to undertake a confirmatory trial as a condition for seeking FDA approval. Successful approval would lead to the establishment of a specialized team focused on supporting the therapy's commercialization. Given the concentrated nature of the patient base and the medical specialists involved, Spruce believes it can effectively reach the market with a focused team and personalized patient initiatives.

Globally, Spruce aims to commercialize TA-ERT and other investigational products in various developed countries. Plans are in place to establish commercial operations in the U.S., EU, and U.K., while exploring regional partnerships in other international markets. The strategy also includes leveraging a network of third-party distributors to expand reach.

The science behind TA-ERT involves a fusion protein designed for patients who lack a specific enzyme activity. The therapy has achieved several designations, such as fast-track, rare pediatric disease, and orphan drug status, in both the U.S. and the EU. The FDA's confirmation of a surrogate biomarker for clinical benefit reinforces the therapy's potential for accelerated approval.

Financially, Spruce Biosciences reported a cash reserve of $38.8 million as of the end of 2024, with a planned runway through 2025. This financial position supports the company’s ongoing operations and strategic ambitions.

In summary, Spruce Biosciences’ acquisition of TA-ERT marks a new chapter in its mission to develop transformative therapies for rare neurological disorders. With an eye on future regulatory submissions and commercial opportunities, the company is strategically positioned to make significant advances in the treatment of MPS IIIB and other diseases with high unmet medical needs.