Stealth Peptides, Inc. announced positive oral Bendavia(TM) clinical results. The Phase I clinical trial demonstrated that oral Bendavia achieved plasma concentrations shown to be cardioprotective in multiple models of acute and chronic cardiac diseases including heart failure. Bendavia is a compound that targets mitochondria to restore bioenergetics and organ function in cardiovascular and metabolic diseases.

The Phase I clinical trial was a placebo controlled, ascending dose study of healthy volunteers to evaluate the clinical safety, tolerability and pharmacokinetics of oral Bendavia. 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. Currently, Stealth is enrolling a Phase II acute kidney injury (AKI) clinical study to assess Bendavia's improvement of renal function in patients with hypertension and severe unilateral renal artery stenosis after treatment with angioplasty.

In cardiovascular disease, Stealth's Phase II ACS study is focused on ischemia reperfusion and microvascular injuries including the extent of 'no reflow' for patients experiencing acute ST--segment elevation myocardial infarction (STEMI).