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pillsNephrilin™ is a novel intervention for disease processes triggered by stress. This medicine could potentially save thousands of lives and spare the healthcare system billions of dollars by alleviating critical care morbidity and mortality, kidney failure, hypertension, diabetes and a variety of other human disease processes. Nephrilin™ has shown efficacy in several animal models of human disease.

Nephrilin™ is a first-in-class injectable peptide drug for protecting high-risk populations from trauma-induced systemic inflammatory conditions. An exclusive-rights comprehensive intellectual property portfolio covers this molecule, its novel biological target and the underlying intelligent delivery technology in the US and in most major markets worldwide.

A wide range of potential indications has been identified for this novel molecule, based on preclinical data and the current scientific understanding of its mechanism of action. Nephrilin™ inhibits stress-induced oxidative and inflammatory dysfunctions in trauma, cancer metastasis, and complications of metabolic disease, including diabetic and hypertensive nephropathies. Although these conditions are initially triggered by diverse causes, a shared underlying oxidative-inflammatory dysfunction is believed to substantially complicate the disease process. Nephrilin™ is not a classical anti-inflammatory drug per se, but a suppressor of dysfunctional inflammatory response to stress.

Early warning of systemic inflammation in ICU patients is provided by clinically validated markers of acute kidney injury (AKI) such as urinary NGAL (uNGAL). AKI is diagnosed in approximately 735,000 ICU patients in the US annually, and is associated with dramatically higher morbidity, mortality and hospital costs. While 5.5% of non-AKI ICU patients die within 2-weeks, AKI stages I-III exhibit 8.8%, 11.4% and 26.3% mortality respectively. Trauma-associated AKI incidence has been increasing over the past decade, marked by elevated uNGAL levels within hours of insult and a catastrophic systemic inflammatory response. In three different experimental models of AKI, Nephrilin™ significantly abrogated the hyper-inflammatory response to trauma.

Critical care expenditures exceed $180 billion annually in the US. The average cost for an ICU patient is about $3,000 per day. Reducing the inflammatory dysfunction in the high-uNGAL critical care population by 50% would save an expected 10,700 lives and $0.5 billion annually. The initial market opportunity for Nephrilin™ in the critical care space is estimated at over $455 million annually.

 




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