Key Highlights
- Stephen Grant, MD, joins Saghmos Therapeutics as Chief Regulatory Officer, bringing over 20 years of FDA experience.
- Saghmos is developing ST-62516 (trimetazidine), aimed at reducing risks of AKI and MACKE following PCI procedures.
- The company’s IND for ST-62516 was cleared by the FDA in 2023, addressing an unmet need in cardiorenal complication prevention.
Source: Business Wire
Notable Quotes
- “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,” – Anna Kazanchyan, MD, Founder and CEO at Saghmos
- “Impaired kidney function is associated with a high risk of morbidity and mortality after PCI…I am excited about working with Saghmos to bring this drug to patients,” – Stephen Grant, MD, Chief Regulatory Officer at Saghmos Therapeutics
SoHC's Take
Saghmos Therapeutics’ strategic move to appoint Dr. Stephen Grant as Chief Regulatory Officer underscores a significant step forward in the fight against cardiorenal complications post-PCI. Dr. Grant’s extensive background with the FDA, particularly in cardiology and nephrology, positions him as a pivotal asset in navigating the regulatory pathways for ST-62516. This drug represents a beacon of hope for patients undergoing PCI, especially those grappling with comorbidities that heighten the risk of acute kidney injury (AKI) and major adverse cardiac and kidney events (MACKE).
ST-62516’s development is particularly noteworthy in the context of over one million PCI procedures performed annually in the U.S., half of which involve patients with comorbidities. With no FDA-approved drugs currently available to prevent or treat AKI and MACKE, ST-62516 could fill a critical gap, offering protection to all PCI patients, not just those with existing comorbidities. The commitment of Saghmos Therapeutics to this cause, supported by Dr. Grant’s expertise, heralds a promising advance in cardiorenal health management.
