Spruce completes pre-BLA meetings with FDA for MPS IIIB therapy

Spruce Biosciences Inc. has completed pre-Biologics License Application (BLA) meetings with the U.S. Food and Drug Administration (FDA) for its MPS IIIB therapy, tralesinidase alfa. The FDA found the company's drug substance and drug product analytical comparability strategies reasonable, and aligned with Spruce on the overall content and format of the planned BLA.

Spruce plans to submit its BLA in the fourth quarter of 2026 on the accelerated approval pathway based on reduction of cerebrospinal fluid heparan sulfate non-reducing ends. The therapy has received several designations in the U.S. and EU, and may be eligible for a rare pediatric disease priority review voucher upon approval. Sanfilippo Syndrome Type B is an ultra-rare genetic disease with no FDA-approved therapies currently available.

Spruce has administered the therapy to 22 individuals diagnosed with MPS IIIB across three clinical studies.

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