Stealth Peptides Reports Successful Clinical Study of Oral Bendavia

Positive Data Broadens Bendavia’s Potential for Chronic Heart Failure and Cardioprotection

BOSTON, MA, January 22, 2013–(BUSINESS WIRE)– Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies for cardiovascular disease and its complications, announced today positive oral Bendavia™ clinical results. The Phase I clinical trial demonstrated that oral Bendavia achieved plasma concentrations shown to be cardioprotective in multiple models of acute and chronic cardiac diseases including heart failure. Bendavia is a compound that targets mitochondria to restore bioenergetics and organ function in cardiovascular and metabolic diseases.

Stealth is developing oral Bendavia to treat chronic heart failure (CHF) patients, and is currently enrolling a Phase II acute coronary syndrome (ACS) study. At the 2012 American Heart Association annual meeting, Dr. Hani Sabbah, Director of Cardiovascular Research at the Henry Ford Health System in Detroit, noted that for CHF, “Bendavia offers a completely innovative approach to treating heart failure by improving mitochondrial function, thus providing needed fuel to the energy–starved heart. Given Bendavia’s unique mechanism of action and its ability to consistently improve left ventricular performance on par with presently approved drugs, but without impacting heart rate or blood pressure, it has the potential to be additive to current standard of care therapies in heart failure.”

The Phase I clinical trial was a placebo controlled, ascending dose study of healthy volunteers to evaluate the clinical safety, tolerability and pharmacokinetics of oral Bendavia. 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 lead clinical program for oral Bendavia is in CHF, an indication with a rapidly growing prevalence worldwide and with clear clinical metrics for FDA approval. Reliable preclinical models for CHF have demonstrated Bendavia’s beneficial cardioprotective effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under multiple pathological conditions, including those along the continuum of cardiovascular disease such as atherosclerosis. Contrary to prior therapeutic strategies for acute and chronic heart disease 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 kidney disease as previously reported at the 2012 American Society of Nephrology annual meeting.

Stealth’s CMO Dr. Richard Straube commented “We are extremely pleased by the positive results from our first oral Bendavia clinical study. Given the role of mitochondrial dysfunction in chronic disease, Bendavia is a promising therapeutic candidate for heart failure and kidney disease patients.”

“The successful completion of our Phase I trial with oral Bendavia represents an important developmental milestone for us,” remarked Stealth CEO, Travis Wilson. “Based on encouraging data from our clinical and nonclinical studies, we feel that Bendavia has the potential to be a significant advancement to the chronic treatment of cardiorenal and metabolic disorders including those that are rare and orphan diseases.”

Currently, Stealth is enrolling a Phase II acute kidney injury (AKI) clinical study to assess Bendavia’s improvement of renal function in patients with hypertension and severe unilateral renal artery stenosis after treatment with angioplasty. In cardiovascular disease, Stealth’s Phase II ACS study is 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 ACS 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 cardiorenal 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.