Enrollment commences in Stealth Peptides' Bendavia Phase II clinical study for acute STEMI

Jun 25 2012

Stealth Peptides Incorporated (Stealth), a privately held biopharmaceutical company developing innovative therapies for cardiovascular disease and its complications, announced today that the first patient was enrolled in its multinational Phase II clinical study with Bendavia™ focused on ischemia reperfusion and microvascular injuries for patients experiencing acute ST-segment elevation myocardial infarction (STEMI). 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.

“Our initiation of this Phase II study marks a key developmental milestone for Bendavia. Based on the encouraging data from our Phase I and preclinical studies, we believe Bendavia is a promising therapeutic candidate for cardiovascular disease and its complications including renal and skeletal muscle dysfunction.”

Stealth's Phase II clinical study, EMBRACE-STEMI™ (Evaluation of the Myocardial effects of Bendavia for reducing Reperfusion injury in patients with Acute Coronary Events), is scheduled to enroll 300 patients across 40 sites within the United States and Europe. EMBRACE-STEMI is designed to assess the effectiveness of Bendavia on reducing the area of cardiac muscle affected by myocardial infarction and microvascular dysfunction. Bendavia offers a novel approach to the treatment of cardiovascular disease and reperfusion injury, a common complication of interventional procedures for acute myocardial infarction (AMI) and coronary bypass surgery.

"Most of our cardiovascular and heart attack strategies have focused on opening arteries, but not on preventing reperfusion injury, or the damage that can result from opening an artery. Although effective treatments to reduce or prevent reperfusion injury have proven elusive, Bendavia is an exciting new therapy that preserves mitochondrial bioenergetics under stress and blocks permeability pore opening, minimizing reperfusion injury. Bendavia has the potential to fill an unmet need for patients having large heart attacks or experiencing poor revascularization due to microvascular no-reflow," said EMBRACE-STEMI's study chairman C. Michael Gibson, M.S., M.D., Interventional Cardiologist and Chief of Clinical Research in the Cardiovascular Division at Beth Israel Deaconess Medical Center in Boston, an affiliate of Harvard Medical School.

Standard animal models for AMI have demonstrated Bendavia's beneficial myocardial effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under multiple pathological conditions, including reperfusion and microvascular injury. Contrary to prior therapeutic strategies for ischemia reperfusion injury and AMI 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 be a strong renal protectant in preclinical models and holds promise as a treatment for disorders such as acute and chronic kidney disease.

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 Phase I and preclinical studies, we believe Bendavia is a promising therapeutic candidate for cardiovascular disease and its complications including renal and skeletal muscle dysfunction." Stealth is also currently initiating a Phase II renal clinical study with Bendavia focused on acute kidney and microvascular injuries for patients undergoing interventional renal artery angioplasty.