Saghmos to launch phase 3 study with patent for ST-62516, trimetazidine
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Saghmos Therapeutics Inc. announced the issuance of the U.S. Patent No. 11,123,345 for its product ST-62516, also known as trimetazidine, along with its plans for a phase 3 study of the drug.
“This patent lays the foundation for Saghmos’ growing intellectual property estate, including pending international patents, as well as additional patent applications that are in preparation,” Anna Kazanchyan, MD, CEO of Saghmos, said in a press release.
Trimetazidine, a mitochondrial metabolic modulator, is designed to reduce kidney injury in patients with chronic kidney disease undergoing contrast procedures. Currently, there are no FDA approved drugs for contrast-induced kidney injury.
Saghmos intends to launch a phase 3 study of ST-62516, while holding the ‘345 patent through 2037. Researchers will recruit patients with severe CKD or patients with moderate CKD and an additional comorbidity, such as diabetes. As contrast-induced kidney injury disproportionately affects Black patients, Kazanchyan told Healio she hopes limiting the participant population to those with CKD and additional comorbidities will allow for Black patients to be “more adequately represented.”
“In the phase 3 study, patients will first receive the study drug or the placebo within a certain time window before the procedure, and then they will continue to receive treatment for 90 days post-procedure. While patients are in the hospital, they will get saline hydration as per local institution guidelines. Then, we'll evaluate these patients for the primary endpoint and the secondary endpoint,” Kazanchyan told Healio. “We'll be evaluating the proportion of patients with any major adverse renal and cardiac events through day 90. This would include things such as death, heart attack, heart failure, hospitalization for renal or cardiac complications and CKD progression as assessed by eGFR. Now, we are looking at contrast-induced kidney injury, but that is only a secondary endpoint, and the other secondary endpoint is the 30-day readmission rate.”
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