BURLINGAME, Calif.– Inflammatix, a pioneering molecular diagnostics company, announced today that the National Institute of General Medical Sciences, part of the National Institutes of Health, has awarded the company a Small Business Innovation Research (NIH SBIR) Direct-to-Phase II grant of $1.7 million. The funding will be used to develop a rapid diagnostic that will identify immune subtypes (“endotypes”) of sepsis to enable better therapy selection and resource allocation.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host immune response to infection. While over 100 clinical trials have been conducted attempting to modulate the immune response to sepsis, there have been no successful approvals of immunomodulatory therapies. Before COVID-19, sepsis claimed approximately 270,000 lives each year in the U.S. and was estimated to be responsible for 20 percent of all deaths worldwide. Severe COVID-19 is also a form of sepsis.
“In sepsis, the body’s immune system becomes dysregulated and starts to damage the patient directly. For decades, physicians have hoped that modulating the immune response to sepsis would improve outcomes, but this hasn’t yet come to pass. We believe that patients with sepsis are too variable for a ‘one-size-fits-all’ approach to therapy and have shown that identifying immune subtypes of sepsis may allow for a precision approach to treatment,” said Inflammatix CEO and Co-Founder Tim Sweeney, MD, PhD.
He continued, “Fifty years ago, cancer was known primarily by anatomy: breast, skin, blood. The advancement of precision medicine has brought an understanding of each cancer’s unique molecular profile, which has unlocked revolutionary therapies and driven improvements in survival. We believe that critical illness, and sepsis in particular, can benefit from the same approach. We are grateful for the support from the NIH for our novel approach, which may allow the medical community to identify improved treatment regimens, leading to the discovery of new targets or pathways for endotype-specific therapies and/or the repurposing of available drugs. Our ultimate goal is to definitively link a patient sepsis subtype with a therapeutic intervention, to make a meaningful improvement in the treatment of sepsis globally.”
The company’s work has identified three unique sepsis subtypes (“endotypes”) using host immune mRNA signatures, and these endotypes may be differentially responsive to therapy. The NIH funding will enable further development of the endotypes signature and development of a rapid, 30-minute test on the company’s proprietary point-of-care system. Further work will identify existing or new therapeutics that match to the endotypes for clinical study. The company is actively working with therapeutics partners on this approach.
The Inflammatix approach – known as host-response diagnostics – rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm. The company is developing other host-response diagnostic tests that identify the presence and type of infection (viral or bacterial) and predict the risk of severe disease, which could enable physicians to make more informed decisions for patients with acute infection and sepsis. All tests will run on the company’s cartridge-based, point-of-care system in under 30 minutes.
