Singaporean biotech Shanton Pharma has reported positive top-line results from a Phase IIb clinical trial of its investigational gout therapy SAP-001 in patients that do not respond to existing treatments.
The six-month study showed that nearly all patients who received a daily dose of SAP-001 at 30mg or 60mg alongside conventional therapies met the treatment goal of reducing serum uric acid levels below 6mg/dL by the end of month three. This compares to around 10% of patients on conventional therapy alone.
Shanton said the urate-lowering effects persisted through to the end of treatment and were supported by a favorable safety profile. The company emphasized that this is the first time an oral treatment has demonstrated such results in this population, which typically requires intravenous uricase therapy.
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