Spruce Biosciences Outlines MPS IIIB Drug Plans at Conference

Company targets Q4 BLA submission for enzyme replacement therapy

Mar. 2, 2026 at 9:07pm

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Executives from Spruce Biosciences (NASDAQ:SPRB) discussed regulatory plans, clinical data highlights, and commercial considerations for the company's lead program in Sanfilippo syndrome type B (MPS IIIB) during a presentation at the Oppenheimer Healthcare Conference. The company is planning to submit a biologics license application (BLA) for its enzyme replacement therapy in Q4 2026, with potential approval in mid-2027.

Why it matters

MPS IIIB is a rare, devastating genetic disorder that causes progressive neurological damage and for which there are currently no approved treatments. Spruce's enzyme replacement therapy, administered directly into the cerebrospinal fluid, aims to address the profound central nervous system involvement in this disease.

The details

Spruce's therapy, originally developed at BioMarin, is a fusion protein combining the NAGLU enzyme with a truncated IGF-2 to facilitate cellular uptake and lysosomal delivery. The company recently held positive meetings with the FDA, which agreed to use heparan sulfate as a 'reasonably likely surrogate endpoint' to support accelerated approval. Spruce has observed durable biomarker control and clinical benefits on cognitive and adaptive behavior measures in trials, with earlier treatment associated with better outcomes.

  • Spruce plans to submit the BLA in Q4 2026.
  • The company expects a potential approval decision around mid-2027.

The players

Spruce Biosciences

A clinical-stage biopharmaceutical company developing therapies for rare endocrine and dermatological disorders, headquartered in San Diego, California.

Dr. Javier Szwarcberg

Chief Executive Officer of Spruce Biosciences.

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