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.