Precision Immunology Therapies
Preclinical
ARDS is the most common cause of death due to COVID-19. Even before the pandemic, ARDS was one of the most common causes of death and disability, affecting people of all ages – from infants to the elderly – and costing healthcare systems billions of dollars each year. Patients suffering from ARDS have severe lung damage with inflammation which prevents them from getting enough oxygen into their blood. Patients are usually treated in the intensive care unit (ICU) and standard of care is to place them on ventilators, which is both invasive and costly. COVID-19 patients who develop ARDS may require mechanical ventilation anywhere from a few days to a few months depending on severity and scope of organ damage. Despite this intensive intervention, more than one third of these patients will unfortunately die. ARDS is a heterogeneous condition, with significant biological differences between patients. This makes ARDS a challenging condition to study in a clinical trial or treat in a clinical setting, because patients respond differently to treatments and interventions. While researchers and clinicians are aware of these differences, they do not currently have the ability to easily stratify patients and identify biologically defined subgroups that are more, or less, likely to respond to certain treatments and interventions. “Precision medicine in critical care has long been a goal that healthcare has struggled to attain. Endpoint Health’s tool could help turn that vision into a reality,” said Dr. Todd Rice, Director of the Medical Intensive Care Unit at Vanderbilt University Medical Center.
Our digital therapy response test has the potential to create a new standard of care for ARDS patients and improve treatment for COVID-19 patients. Researchers and clinicians know that ARDS is a heterogenous condition and that saving patients’ lives requires personalized treatments, but they lack the data, diagnostic tools, and targeted therapeutics to improve patient care. Our test has demonstrated the ability to identify subgroups of patients that are biologically distinct and therefore likely to respond differently to therapeutic interventions. Thus, the test facilitates precision approaches in ARDS treatment – a major scientific breakthrough. Our research has confirmed the existence of two distinct subgroups of ARDS patients using a novel clustering method based on nine routinely collected clinical data. These two patient subgroups have also been identified in previous studies, but the methods used to identify them are too complex to be employed in routine clinical practice. For example, models from other researchers use up to 40 variables, including non-standard biomarkers and other variables that are not readily available at a patient’s bedside. These limitations are part of the reason that ARDS patient outcomes remain poor. In contrast, the Endpoint Health digital therapy response test uses a simpler methodology that incorporates only nine routinely collected EHR variables to stratify ARDS patients into biologically distinct groups that are predictive of therapeutic response. This approach can enable precision clinical trial enrollment and the development of targeted therapies, without the added burdens of developing new IVD tests and validating biomarkers measured by those tests.
Our organization has partnered with numerous global healthcare delivery systems and clinical research institutions. In North America, we have partnered with the EMPACT Network, a group of internationally recognized clinical research and patient care institutions, which are working to execute late-stage interventional trials that evaluate personalized treatments and precision therapies. This group of world-class researchers are working to codify the molecular, clinical, and behavioral markers of disease and treatment response; use novel precision technologies to guide patient enrollment and treatment selection in clinical trials; and personalize treatment in routine care and with novel targeted therapeutics. Members of the EMPACT network include Brown University, Cleveland Clinic, Emory Healthcare, Intermountain Healthcare, Johns Hopkins, Montefiore Health System, Oregon Health and Science University, UCHealth, UCLA Health, Vanderbilt University, and Wake Forest Baptist Health. In South America, Endpoint Health has partnered with BRICNet, an association of intensivists, clinicians and researchers, committed to being the primary organization in Brazil and in emerging economies in conducting collaborative clinical research that promotes the advancement of critically ill patient care. In addition, Endpoint Health is working with ANZICS in Australia, the leading advocate on all intensive care related matters in Australia and New Zealand. ANZICS leads the world in intensive care research through its Clinical Trials Group and patient databases, including the Adult Patient Database, the Paediatric Intensive Care Registry and Critical Care Resources.
