Stealth announces results from three Bendavia Phase I clinical trials for mitochondrial dysfunction

Apr 9 2012

Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies for diseases with unmet medical needs, announced today the results from three Phase I clinical trials of Bendavia, a novel compound that targets the mitochondrion to treat mitochondrial dysfunction, including ischemia reperfusion and microvascular injury. The studies evaluated the potential for interactions between Bendavia and several drugs routinely administered to patients undergoing in-hospital interventional procedures. During the studies, volunteers received a single dose of Bendavia administered as an intravenous infusion followed by a standard dose of heparin, aspirin or clopidogrel. Results from these clinical trials indicate that Bendavia does not appear to affect the pharmacodynamics of these commonly used drugs. Safety data from these studies and preliminary results also demonstrate that Bendavia appears to be safe and well-tolerated at the doses evaluated, with no serious adverse events reported. Pharmacokinetic analysis from related clinical studies also showed highly predictable dose-proportional exposure of Bendavia among volunteers.

The initial clinical program for Bendavia is the treatment of ischemia reperfusion injury, a common complication of interventional procedures for acute myocardial infarction (AMI) and coronary bypass surgery. Standard animal models for AMI demonstrate Bendavia's beneficial myocardial effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under pathological conditions for ischemia reperfusion and microvascular injury.

Contrary to prior therapeutic strategies for ischemia reperfusion injury and AMI that focused on uni-targeted pathways, Bendavia and its mitochondrial directed actions address the more complicated, multifactorial nature of diseases. Specifically, Bendavia maintains electron transport efficiency, mitochondrial respiration and adenosine triphosphate levels and prevents mitochondrial swelling and depolarization. Bendavia also appears to be a strong ophthalmologic protectant in preclinical models and holds promise as a treatment for disorders such as diabetic retinopathy and macular degeneration.

Stealth's CEO, Travis Wilson, remarked "Stealth is very pleased with the drug interaction data and tolerability of Bendavia from these Phase I clinical trials. Based on data from several studies showing Bendavia's potential benefit for such common cardiovascular and metabolic diseases as heart failure and diabetic retinopathy, we feel that it is a unique and promising therapeutic candidate for cardio-renal and ophthalmologic disorders."

Stealth is currently enrolling patients in a multinational Phase II clinical study with Bendavia focused on ischemia reperfusion and microvascular injuries 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.