Saghmos Therapeutics, Inc, a privately owned biopharmaceutical company, has revealed its collaboration with the Duke Clinical Research Institute (DCRI) to optimize and strategize the operationalization of its Phase 3 study for ST-62516, a cardio-renal metabolic modulator.

The objective behind developing ST-62516 is to lower the risk of Acute Kidney Injury (AKI) and Major Adverse Cardiac and Kidney Events (MACKE) post-contrast procedures like percutaneous coronary intervention (PCI). With FDA clearance for ST-62516's IND granted in 2023, Saghmos is now moving towards Phase 3 trials.

Dr. Anna Kazanchyan, the Founder and CEO of Saghmos Therapeutics, expressed appreciation for partnering with DCRI, highlighting their esteemed academic and clinical leadership, as well as operational expertise, which are expected to enhance the Phase 3 study.

Dr. Schuyler Jones, principal investigator and interventional cardiologist at DCRI, stressed the urgency of addressing AKI and its associated cardiac and kidney complications in patients undergoing PCI, particularly those with pre-existing cardiovascular disease, kidney disease, and diabetes. He expressed enthusiasm about collaborating to design the Phase 3 study of ST-62516 to meet this crucial medical need.

Given that over a million PCI procedures are conducted annually in the US, a significant portion of patients with ischemic heart disease, including myocardial infarction, face heightened risks due to comorbidities such as chronic kidney disease and diabetes. Currently, there are no FDA-approved drugs to mitigate these risks. ST-62516 holds promise not only for patients with comorbidities but also for all individuals undergoing PCI, potentially reducing the threat of AKI and MACKE.

 

Source: businesswire.com

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