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SOUTH SAN FRANCISCO - Spruce Biosciences, Inc. (OTCQB:SPRB), which has delivered strong returns over the past year despite recent market volatility according to InvestingPro data, announced Thursday that its tralesinidase alfa enzyme replacement therapy (TA-ERT) demonstrated significant positive results in patients with Sanfilippo Syndrome Type B (MPS IIIB) over a five-year period.
The data showed TA-ERT profoundly reduced cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE), the factor responsible for neurodegeneration in MPS IIIB patients. According to the company, the U.S. FDA has confirmed that CSF HS-NRE is a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval.
The integrated analysis included data from clinical studies 201, 202, and 401, comparing 22 treated patients with untreated patients from natural history studies. Results showed CSF HS-NRE levels decreased by 91.5 ng/mL from baseline over the study period, with most participants experiencing normalization of levels eight weeks after starting therapy. For investors following this development, InvestingPro subscribers can access 17 additional key insights about SPRB’s financial health and market position through detailed Pro Research Reports.
Cognitive function remained stable in treated patients, contrasting with the decline typically seen in untreated children beginning around age five. By age 10, the difference in cognitive scores between treated and untreated groups was 34.66 points.
The therapy also stabilized cortical grey matter volume compared to the decline observed in untreated children. Safety data from up to 7.3 years of exposure showed an adequate profile, with vomiting, fever, and upper respiratory tract infections being the most common adverse events.
MPS IIIB is an ultra-rare genetic disease affecting fewer than 1:200,000 people in the United States. It causes progressive neurodegeneration leading to cognitive impairment, behavioral issues, and eventually death, with life expectancy between 15-19 years. Currently, no FDA-approved therapies exist for the condition.
The findings were presented in a press release statement from the company.
In other recent news, Spruce Biosciences has announced a 1-for-75 reverse stock split of its common stock, which will take effect on August 4, 2025. This move is intended to help the company comply with Nasdaq Capital Market’s minimum bid price requirement, a crucial step for Spruce Biosciences to relist on Nasdaq. The company has already secured approval from Nasdaq to resume trading, contingent on meeting the bid price requirement by August 5, 2025. This stock split was approved by stockholders during a meeting on July 22, 2025. Spruce Biosciences aims to maintain compliance for 20 consecutive trading days following the effective date to ensure its position on Nasdaq. The company’s board views the reverse stock split as a necessary action to meet the exchange’s requirements. These developments mark significant steps in Spruce Biosciences’ efforts to stabilize and enhance its market presence.
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