GREENWICH, Conn.– Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer. Dr. Grant was the former Deputy Director, Division of Cardiology and Nephrology at the FDA. During his more than 20-year career at the FDA, he was responsible for the review of dozens of NDAs and hundreds of INDs for drugs and drug-device combination products for treatment or prevention of cardiovascular diseases. He was also responsible for organizing meetings of the Cardiovascular and Renal Drugs Advisory Committee and participated in working groups that wrote guidance and regulations for drug development.
“We are honored and privileged to work with Dr. Grant. His guidance and his wealth of regulatory experience in the cardio-renal area at the FDA will tremendously benefit our mission to bring ST-62516 to patients,” said Anna Kazanchyan, MD, Founder and CEO of Saghmos.
“Impaired kidney function is associated with a high risk of morbidity and mortality after percutaneous coronary intervention (PCI). Hence providers must frequently make a difficult choice in this population between not performing PCI, even when indicated, or exposing patients to the risk of complications,” Stephen Grant, MD, said. “In this context, a drug such as trimetazidine will be a useful addition to the treatment armamentarium to prevent complications after PCI. I am excited about working with Saghmos to bring this drug to patients.”
Saghmos is developing ST-62516 (trimetazidine), a cardiorenal metabolic modulator to reduce the risk of Acute Kidney Injury (AKI) and Major Adverse Cardiac and Kidney Events (MACKE) after contrast procedures such as PCI. Saghmos’ IND for ST-62516 was cleared by the FDA in 2023. Over one million PCI procedures are performed annually in the US in patients with unstable angina (heart attack). About half of these patients have comorbidities which impact the safety of PCI. This is a major unmet medical need with no FDA-approved drugs available to prevent or treat AKI and MACKE. ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.
Stephen Grant, MD, is the former Deputy Director, Division of Cardiology and Nephrology at the Center for Drug Evaluation and Research (CDER) of the FDA. During his more than 20-year career at FDA, he was also Clinical Team Leader and Clinical Reviewer at the Division of Cardiology and Nephrology. In addition, he served in leadership roles at the Center for Biologics Evaluation and Research (CBER). Prior to his career at the FDA, Dr. Grant was a practicing cardiologist.
Dr. Grant received his MD from Harvard Medical School and completed his residency in Internal Medicine at The George Washington University Medical Center. He is Board-certified in Internal Medicine, Cardiovascular Subspecialty, and completed a cardiology fellowship at The George Washington University Medical Center. In addition, he did a medical fellowship at the National Heart, Lung and Blood Institute, National Institutes of Health, where he was a member of the team that cloned and sequenced apolipoprotein B-100 (apoB), a protein that carries fat and cholesterol around the body.
