Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies, announced today the results of a healthy volunteers Phase I clinical study of Bendavia™, a novel compound that targets the mitochondrion to treat ischemia reperfusion injury. This study evaluated healthy male and female volunteers representing a broad range of adult ages. During the study, volunteers received a single dose of Bendavia administered as an intravenous infusion over an extended period. Safety data from the clinical trial and preliminary results demonstrate that Bendavia appears to be safe and well-tolerated at the dose 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 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 has been shown to improve electron transport efficiency, maintain mitochondrial respiration and adenosine triphosphate levels and prevent mitochondrial swelling and depolarization. Bendavia also appears to be a strong neurologic protectant, which holds promise as a treatment for cardiac arrest and stroke patients.
Dr. Richard Straube, Stealth's CMO, commented, "We are very pleased with the Phase I data and tolerability of Bendavia in healthy volunteers. The plasma levels for this dose are also predictable and consistent with those seen to be effective for significantly reducing infarct sizes in each of our AMI animal models."
Stealth's CEO, Travis Wilson, remarked, "Based on the preliminary results of this Phase I clinical trial and encouraging preclinical data for several acute care conditions, we feel that Bendavia has the potential to be a paradigm shifting therapy for mitochondrial dysfunction, which underlies many common diseases including cardio-renal, neurologic and metabolic disorders."
Stealth is currently initiating a multinational Phase II clinical study with Bendavia focused on ischemia reperfusion injury 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 Acute Myocardial Infarction
Statistics from the AHA indicate that more than 600,000 people within the U.S. die from heart disease and AMI each year, an amount greater than the combined total of mortalities from every type of cancer. As background, ischemia is defined as the inadequate supply of oxygen and nutrients to maintain normal cellular aerobic metabolism. It arises primarily from a lack of blood flow to tissue and is seen in a variety of clinical conditions including stroke, AMI, acute and chronic kidney injury and organ transplantation. In tissues with high metabolic activity, such as the brain and heart, adenosine triphosphate stores are depleted within the first few minutes of ischemia. Standard-of-care reperfusion therapies for AMI include primary percutaneous coronary intervention and thrombolysis. Prompt restoration of blood flow to the ischemic myocardium limits infarct size, which is a major determinant of mortality and morbidity for AMI patients. Paradoxically, the return of blood flow after ischemia can also result in additional cardiac damage and complications. This phenomenon known as reperfusion injury is associated with an array of myocardial, vascular and electrophysiological derangements that can increase infarct size and cause long-term clinical deterioration and complications including heart failure. To date, effective therapies to reduce or prevent reperfusion injury have proven elusive. Through its mitochondrial directed actions, Bendavia appears to be a lead candidate for innovative pharmacologic approaches to reduce ischemia reperfusion injury in patients.
Source:
Stealth Peptides Inc