Company success: Targeson maneuvers deftly through FDA requirements
One of our portfolio companies, Targeson, Inc., announced they have received pre-IND (Investigative New Drug) guidance from the Division of Medical Imaging of the Food and Drug Administration (FDA) concerning TS-07-009, ultrasound imaging agent to aid in the diagnosis of Acute Coronary Syndrome (ACS).
This means Targeson has a clear path to develop TS-07-009 as an ultrasound imaging agent to aid in the diagnosis of ACS.
Chest discomfort accounts for over 6 million patient visits to emergency departments in the United States annually. The current diagnosis of ACS is achieved through 1) assessment of history and risk factors, 2) evaluation of an electrocardiogram (ECG), and 3) assessment of the level of cardiac enzyme biomarkers, primarily troponin. Even with the current diagnostic tools, between 2% and 7% of patients presenting with chest pain at emergency departments are sent home without a diagnosis of ACS, but are subsequently diagnosed with ACS. Conversely, to avoid a missed diagnosis of ACS, nearly 50% of patients presenting with chest pain are admitted, but ACS is confirmed in only 10% to 30% of those cases.
Targeson is the recipient of three separate grants that aided in the development, identification, and gave them the resources to conduct preliminary studies. With their grant from the National Institute of Health, and the NIH Commercialization Assistance Program (CAP), conducted by Larta, Inc., Targeson identified the IND enabling preclinical studies and initial clinical plan and completing the requirements for a pre-IND meeting with the FDA.
“The grants from NIH and the commercialization assistance program from Larta were essential in moving TS-07-009, our lead clinical product, toward clinical development,” remarked Jack DeFranco, CEO of Targeson.
Get the details here.