Top Researchers Present Promising Bendavia Findings at Annual American Society of Nephrology Meeting

Top researchers presented findings showing Bendavia reduced renal and myocardial injury

Boston, MA – November 19, 2012–(BUSINESS WIRE)– Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies for diseases with unmet medical needs, reported today on Bendavia™ study findings presented during the annual American Society of Nephrology (ASN) meeting. Bendavia is a novel investigational compound that targets the mitochondrion to treat mitochondrial dysfunction across the continuum of cardiovascular and renal disease. ASN is a U.S. nonprofit organization that leads the fight against kidney disease by educating healthcare professionals and advancing basic and clinical research. ASN’s “Kidney Week 2012” meeting was held October 30th through November 4th in San Diego, where over 13,000 nephrology professionals gathered to exchange knowledge and learn the latest on scientific and medical advances.

Top researchers collaborating with Stealth presented findings showing Bendavia reduced renal and myocardial injury from both chronic atherosclerotic renal artery stenosis (ARAS) and acute kidney injury in multiple porcine studies. During the studies, animals were treated either chronically with Bendavia after six weeks of ARAS, following a high fat diet, or acutely during renal angioplasty and stenting. Four weeks later, researchers evaluated single kidney renal blood flow (RBF) and glomerular filtration rates (GFR) along with renal microvasculature by CT. Chronic and acute treatment data with Bendavia showed that animals displayed restored kidney function including RBF and GFR, and improved renal microvascular architecture. Conversely, the researchers found that control kidney RBF and GFR remained decreased with compromised renal microvasculature in animals with chronic ARAS or acute kidney injury. Both chronic and acute studies with Bendavia also demonstrated decreased myocardial fibrosis resulting from renovascular hypertension, a common complication of ARAS. The researchers concluded that Bendavia “shows a unique therapeutic potential for improving kidney function and outcomes,” and published their findings in the American Heart Association journal, Hypertension. Their findings were featured on the November cover of the journal and selected as an editor’s choice for the month.

Standard animal models for acute and chronic kidney injury have demonstrated Bendavia’s beneficial renal effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under multiple pathological conditions. Contrary to prior therapeutic strategies for renal dysfunction that focused on uni–targeted pathways, Bendavia and its mitochondria–targeted actions address the more complicated, multifactorial nature of diseases. Specifically, Bendavia maintains electron transport efficiency, mitochondrial respiration and adenosine triphosphate levels, while preventing mitochondrial swelling and depolarization. Research also suggests Bendavia may hold promise as a treatment for chronic heart failure.

Stealth’s CEO, Travis Wilson, remarked, “Stealth is excited about the findings by its collaborating researchers, which suggest Bendavia’s potential for treating the growing prevalence of renal disease worldwide. Based on several of our clinical studies with Bendavia and encouraging preclinical data for chronic and acute conditions, we feel that Bendavia has the potential to be a significant advancement to the treatment of cardio–renal and metabolic disorders including rare and orphan mitochondrial diseases.”

The findings presented at ASN support a Phase II acute kidney injury clinical study that is initiating enrollment and plans to assess the effectiveness of Bendavia on improving renal function affected by hypertension, severe unilateral renal artery stenosis and angioplasty. Stealth is also enrolling a multinational Phase II cardiac clinical study with Bendavia focused on ischemia reperfusion and microvascular injuries including the extent of “no reflow” for patients experiencing acute ST–segment elevation myocardial infarction (STEMI). Stealth’s Phase II cardiac study is termed EMBRACE–STEMI™ for the Evaluation of the Myocardial effects of Bendavia for reducing Reperfusion injury in patients with Acute Coronary Events.

About Stealth Peptides

Stealth is a privately held biopharmaceutical company developing innovative mitochondrial therapies for diseases with unmet medical needs. Stealth has a rich and promising pipeline of preclinical and clinical compounds from a unique class of short peptides (500–700 Daltons each) that target mitochondria. Published, peer–reviewed data for these compounds suggest significant in vitro and in vivo efficacy for metabolic, ophthalmologic, neurologic and cardio–renal related disorders. The intellectual property portfolio around these compounds is exceptionally robust with compositions, including Bendavia, protectable by patent until 2031.

More information regarding Stealth and Bendavia is available at our website.