SAP-001 is Shanton’s lead investigational compound with First- and Best-in-Class potential in uncontrolled gout
Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced topline data of a Phase 2b study in refractory gout patients with its investigational drug SAP-001 that uses a First-in-Class Mechanism of Action targeting a distinct kidney transporter.
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“We are excited and very pleased with the outcome of our Phase 2b clinical study in this difficult-to-treat population of refractory gout patients” says Dr. Bing Li, Shanton’s CEO. “By the end of month 3 in our study, nearly 100% of patients that were confirmed exposed to daily SAP-001 30 and 60 mg dosages on top of conventional therapy reached the study’s therapeutical target (serum uric acid levels below 6mg/dL), compared to only about 10% of patients on conventional treatment who reached that goal. The majority of treatment effects persisted until the end of treatment at month 6 of the study. More than half of those patients confirmed exposed to a daily 60 mg dose reached serum uric acid levels below 3mg/dL. Importantly, the study demonstrated an excellent safety profile in this population.”
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Shanton’s gout program already showed excellent, best-in-class efficacy compared to other Urate Lowering Therapies in prior Phase 1 and 2a studies in regular gout patients, an outcome that has now been repeated in the challenging target population of refractory patients that often have a more severe form of gout with limited treatment options. Dr. Wenfeng Miao, Shanton’s CMO adds: “This is the first successful clinical study with an oral gout drug to treat these refractory patients that normally need to be treated with an intravenous uricase. The efficacy of SAP-001 in this population is very impressive in all dosage groups at all assessed time points across the six months of treatment. We believe that the excellent efficacy and safety outcomes in this study show the exciting potential of our First-in-Class compound with its novel mechanism of action (MOA) that selectively targets a distinct kidney transporter for urate lowering treatment. The medical community has long been looking for this new mechanism in gout to address the shortcomings with conventional MOAs, especially where it comes to treating refractory and tophaceous patients. Our goal is to proceed into pivotal studies with our program later this year to eventually offer a paradigm-shifting gout treatment to our patients and make a big impact in their lives.”
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Source – PR Newswire
