Monday, Raptor Pharmaceutical Corp. (RPTP) announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate or DR Cysteamine in patients with nephropathic cystinosis.
The Phase 2a study demonstrated proof-of-concept for DR Cysteamine, which is Raptor's proprietary, delayed-release, enteric-coated microbead formulation of immediate release cysteamine bitartrate contained in a gelatin capsule. Immediate-release cysteamine bitartrate or IR Cysteamine is the current standard of care for treating cystinosis, the company said.
Raptor stated the results indicated that when given twice daily, the prototype DR Cysteamine formulation was effective at maintaining low white blood cell or WBC cystine levels in subjects with cystinosis. Results also indicated that the prototype DR Cysteamine effectively maintained trough WBC cystine levels within a satisfactory range when patients received around 60% of the previous total daily dose of IR Cysteamine.
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