Bendavia study findings presented during the annual American Society of Nephrology (ASN) meeting
Boston, MA – November 15, 2011–(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 compound that targets the mitochondrion to treat mitochondrial dysfunction including ischemia reperfusion and microvascular injuries. 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 2011” meeting was held November 8th through November 13th in Philadelphia, where over 13,000 nephrology professionals gathered to exchange knowledge and learn the latest on scientific and medical advances.
Researchers collaborating with Stealth presented findings that Bendavia reduced porcine renal injury from atherosclerotic renal artery stenosis (ARAS) and percutaneous transluminal renal angioplasty (PTRA). During the study, animals were treated after six weeks of ARAS, following a high fat diet, with PTRA, renal artery stenting and Bendavia or placebo. Four weeks later, researchers evaluated single kidney renal blood flow (RBF) and glomerular filtration rates (GFR) along with renal microvasculature by CT. The data showed that animals administered Bendavia displayed restored hemodynamics and kidney function including RBF and GFR, and improved microvascular architecture. Conversely, the researchers found that the stenotic kidney RBF and GFR remained decreased with compromised renal microvasculature in control animals. Bendavia, the collaborating researchers reported, “shows a unique therapeutic potential for improving kidney function and outcomes,” and published their findings in an abstract accepted to the 2011 ASN meeting.
The lead clinical program for Bendavia is the treatment of ischemia reperfusion and microvascular injuries, common complications of interventional procedures for acute myocardial infarction (AMI), coronary bypass surgery and renal transplantation. Standard animal models for such interventional procedures demonstrate Bendavia’s beneficial biologic effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under pathological conditions for ischemia reperfusion and microvascular injuries.
Contrary to prior therapeutic strategies for cardiac and renal disorders that focused on uni–targeted pathways, Bendavia and its mitochondrial directed actions address the more complicated, multifactorial nature of disease. Specifically, Bendavia appears to maintain electron transport chain efficiencies under substantial oxidative stress, thereby preserving mitochondrial respiration and adenosine triphosphate levels and preventing mitochondrial swelling and depolarization. Bendavia also appears to be a strong neurologic and ophthalmologic protectant in preclinical models and holds promise as a treatment for disorders such as Parkinson’s disease and macular degeneration.
Stealth’s CEO, Travis Wilson, remarked, “Stealth is excited about the findings by its collaborating researchers and 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, neurologic and ophthalmologic disorders including rare and orphan mitochondrial diseases.”
The findings support a planned Phase II renal clinical study of Bendavia during 2012. Stealth is currently initiating a multinational Phase II 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 clinical trial 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 Peptides Inc. (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 vitroand 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.