Stealth Peptides Initiates Patient Enrollment for Novel Treatment of Acute Kidney Injury

Clinical Study Broadens Bendavia’s Potential for Acute and Chronic Kidney Disease

Boston, MA — January 16, 2013—(BUSINESS WIRE)—Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies for cardiovascular and renal disease, announced today that the first patient was enrolled in its Phase II clinical study with Bendavia™ for the treatment of acute kidney injury (AKI) and renal microvascular dysfunction in hypertension. The study was initiated based on Bendavia research showing “unique therapeutic potential for improving kidney function and outcomes,” as published in the American Heart Association journal, Hypertension. Several prior clinical studies demonstrated that Bendavia appears to be safe and well–tolerated with no serious adverse events across a broad dose range with highly predictable pharmacokinetics.

Stealth’s Phase II AKI clinical study is intended to assess Bendavia’s improvement of renal function in patients with hypertension and severe unilateral renal artery stenosis, after treatment with angioplasty. Bendavia is a compound that targets mitochondria to restore bioenergetics and organ function in acute and chronic kidney diseases. Through its unique mechanism of action, Bendavia offers an innovative approach to the treatment of AKI, a common and growing problem among renal patients worldwide.

“Effective treatments to reduce or prevent AKI have proven elusive. Bendavia’s therapeutic approach may prevent kidney damage by preserving mitochondrial energetics during an acute injury, improving renal function with long–term benefits. Bendavia has the potential to fill an unmet need for the growing number of patients with poor renal function and those experiencing kidney microvascular dysfunction,” said Dr. Richard Straube, Stealth’s CMO.

Research for acute and chronic kidney disease has demonstrated Bendavia’s beneficial renal effects and confirmed the significance of its novel mechanism of action, which preserves mitochondrial function under multiple pathological conditions, including hypertension, diabetes, severe renal artery stenosis and microvascular injury. Contrary to prior therapeutic strategies for AKI 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. Bendavia also appears to hold promise as a treatment for acute and chronic heart failure as previously reported at the 2012 American Heart Association annual meeting.

Stealth’s CEO, Travis Wilson, remarked “Our initiation of this Phase II study marks a key developmental milestone for Bendavia. Based on the encouraging data from our clinical and preclinical studies, we believe Bendavia is a promising therapeutic candidate for both acute and chronic kidney disease.” Stealth is also currently enrolling a 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, and is led by Dr. C. Michael Gibson, Interventional Cardiologist and Chief of Clinical Research in the Cardiovascular Division at Beth Israel Deaconess Medical Center.

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 on Stealth and Bendavia is available at our website.