Positive results from Stealth's Bendavia Phase I renal impairment study

Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies, announced today the results of a Phase I renal impairment study with Bendavia™. Bendavia is a novel compound that targets the mitochondrion to treat mitochondrial dysfunction including ischemia reperfusion and microvascular injuries. This clinical study evaluated patients representing a broad range of renal functions including moderate and severely impaired patients as assessed by 24-hour creatinine clearance. During the study, patients received a single dose of Bendavia administered as an intravenous infusion over a four hour 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. Bioanalytical analyses from this and related clinical studies also showed highly predictable pharmacokinetics for Bendavia.

The initial 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 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 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 renal protectant in preclinical models, which holds promise as a treatment for stroke and renally impaired patients.

Dr. Richard Straube, Stealth's CMO, commented, "We are very pleased with the Phase I data and tolerability of Bendavia in renally impaired patients. The plasma levels from this study also appeared to be safe and predictable across a spectrum of mild, moderate and severely impaired patients."

Stealth's CEO, Travis Wilson, remarked "Based on the preliminary results of this Phase I clinical trial and encouraging preclinical data for several chronic and acute conditions, we feel that Bendavia has the potential to be a significant advancement to the treatment of cardio-renal, neurologic and metabolic disorders including rare and orphan related diseases."

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.

Source: Stealth Peptides