Saghmos Therapeutics, Inc. (Saghmos), a privately owned biopharmaceutical firm, has disclosed its collaboration with the Duke Clinical Research Institute (DCRI) to enhance and strategize the implementation of Saghmos’ Phase 3 study for its cardio-renal metabolic modulator ST-62516.
Saghmos Therapeutics, Inc. (Saghmos) is advancing the development of ST-62516, aimed at mitigating the risk of Acute Kidney Injury (AKI) and Major Adverse Cardiac and Kidney Events (MACKE) following contrast procedures like percutaneous coronary intervention (PCI). The FDA cleared Saghmos’ Investigational New Drug (IND) application for ST-62516 in 2023.
Dr. Anna Kazanchyan, Founder and CEO of Saghmos Therapeutics, expressed gratitude for the collaboration with the Duke Clinical Research Institute (DCRI), renowned for its academic and clinical excellence. The collaboration aims to optimize all facets of Saghmos’ Phase 3 study. Dr. Schuyler Jones, principal investigator and interventional cardiologist at DCRI, emphasized the critical need for interventions addressing AKI and MACKE in PCI patients, particularly those with pre-existing cardiovascular diseases, kidney diseases, and diabetes.
Each year, over a million PCI procedures are performed in the US, predominantly on individuals with ischemic heart disease, including heart attack sufferers. Approximately half of these patients have comorbidities such as chronic kidney disease and diabetes, or are elderly, amplifying the risks associated with PCI. The absence of FDA-approved drugs underscores the urgency of addressing this unmet medical need. ST-62516 holds promise to benefit all PCI patients by mitigating the threats of AKI and MACKE.
The Duke Clinical Research Institute (DCRI), affiliated with the Duke University School of Medicine, stands as the world’s largest academic clinical research organization. Renowned for its pioneering work in cardiovascular research, DCRI conducts transformative clinical trials across various therapeutic domains. Leveraging clinical expertise and academic leadership, DCRI designs and executes innovative trials, contributing to enhanced healthcare quality globally.
Saghmos Therapeutics is actively developing ST-62516 (trimetazidine) to alleviate cardiorenal complications post-PCI. The company holds a US patent (Patent number 11,123,345) for AKI prevention and treatment after contrast procedures, with additional patents pending in the US and Japan. Noteworthy recent appointments include Fred Hassan as Chairman of the Board of Directors and Dr. Stephen Grant as Chief Regulatory Officer.
