Saghmos Therapeutics Announces Collaboration with Duke Clinical Research Institute to Optimize Phase 3 Cardio-Renal Metabolic Study

DCRI is the world’s largest academic clinical research organization and a pioneer in cardiovascular clinical research, combining clinical and academic leadership with operational expertise

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced it will partner with the Duke Clinical Research Institute (DCRI) to optimize all aspects of and plan the operationalization of Saghmos’ Phase 3 study for its cardio-renal metabolic modulator ST-62516.

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Saghmos is developing ST-62516 to reduce the risk of Acute Kidney Injury (AKI) and Major Adverse Cardiac and Kidney Events (MACKE) after contrast procedures such as percutaneous coronary intervention (PCI). Saghmos’ IND for ST-62516 was cleared by the FDA in 2023.

“We are honored to collaborate with the DCRI and its high caliber academic and clinical leadership, as well as its operational experts to optimize all aspects of our Phase 3 study,” commented Anna Kazanchyan, M.D., Founder and CEO of Saghmos Therapeutics. “DCRI has conducted many groundbreaking cardiovascular studies, and their deep knowledge of this area is invaluable to Saghmos.”

“We are delighted to work with Saghmos. Acute kidney injury and its cardiac and kidney sequelae are an area of high unmet need in patients undergoing PCI who have pre-existing cardiovascular disease, kidney disease and diabetes,” said Schuyler Jones, M.D., who is the principal investigator and an interventional cardiologist with the DCRI. “We are excited about the opportunity to collaborate and provide input on the design of the Phase 3 study of ST-62516 to address this need and become the standard of care.”

Over one million PCI procedures are performed annually in the US in people with ischemic heart disease, including myocardial infarction (heart attack). About half of these individuals have comorbidities such as chronic kidney disease, diabetes, or are aged 75 and older, all of which impact the safety of PCI. These comorbidities, in combination with certain procedure-related factors, increase the risk of AKI and MACKE. This is a major unmet medical need with no FDA-approved drugs available. ST-62516 could benefit all people undergoing a PCI, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

About Duke Clinical Research Institute (DCRI)

The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, is the world’s largest academic clinical research organization (ARO). It is a pioneer in cardiovascular clinical research and conducts groundbreaking clinical research across numerous therapeutic areas. DCRI designs and implements innovative clinical trials that advance the fundamental understanding of health and contribute to improved quality of care.

DCRI combines clinical expertise and academic leadership with the comprehensive capabilities of a full-service contract research organization, providing scientific leadership, operational expertise, best-in-class statistics and informatics, and extensive knowledge of clinical practice patterns and regulatory requirements, across the United States and worldwide.

About Saghmos Therapeutics

Saghmos Therapeutics is developing ST-62516 (trimetazidine) to reduce the risk of cardiorenal complications after PCI. The company has an issued US patent (Patent number 11,123,345) for the prevention and treatment of acute kidney injury after contrast procedures, and Notices of Allowance for additional patents in the US and Japan. Saghmos recently announced the appointment of Fred Hassan as Chairman of the Board of Directors and Dr. Stephen Grant as Chief Regulatory Officer.

Forward looking statements

This press release contains forward-looking statements, pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Saghmos Therapeutics’ business, intellectual property, clinical and regulatory plans, commercial potential, and the value and benefits of ST-62516. In any forward-looking statement in which Saghmos expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Saghmos’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources, uncertainties and changes related to the law and regulatory process, and general changes in the economic environment. These forward-looking statements are based on our current expectations. Saghmos does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

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