KAI Pharma Reports Data on Treatment for Heart Attack

KAI Pharmaceuticals has announced that a Phase I/II trial evaluating KAI-9803 for reperfusion injury showed early indications that it may reduce damage to the heart and improve cardiac function in heart attack patients undergoing treatment with balloon angioplasty. The trial also showed that KAI-9803 demonstrated a favorable safety profile.

"Although this was an exploratory study, we believe that KAI-9803 could potentially benefit the large number of patients who suffer from heart attacks annually and therefore warrants larger studies to determine its therapeutic value," Matthew Roe, lead study author, said.

According to the company, there are no therapeutics currently on the market for treating the muscle damage that occurs as a result of a heart attack, making KAI-9803 potentially a first-in-class agent and breakthrough therapeutic approach for acute myocardial infarction (AMI), or heart attack.

KAI-9803 is an isozyme-selective delta protein kinase C (PKC) inhibitor designed to reduce injury associated with a heart attack. The delta PKC inhibitor is activated during a heart attack, causing a cascade of events that damages heart tissue. KAI-9803 is designed to selectively inhibit delta PKC, consequently blocking this deadly cascade. KAI-9803 has received fast-track designation from the FDA for the AMI indication.

The DELTA-MI trial, an exploratory, first-in-human study, found that patients receiving intracoronary injections of KAI-9803 experienced less damage to the heart muscle compared with those patients receiving placebo. The trial evaluated KAI-9803 in 154 patients who suffered from acute anterior ST-segment elevation myocardial infarction. Those patients were randomized 2-1 to receive intracoronary injections of KAI-9803 or a placebo in four dose groups -- 0.05, 0.5, 1.25 or 5.0 mg.

Patients at all dose levels demonstrated less myocardial necrosis (destruction of the heart muscle cells) and improved electrical activity of the heart (an indicator of heart muscle health). The median reduction in myocardial necrosis ranged from 18 percent to 25 percent across the four dose groups. Similarly, the median improvement in electrical activity of the heart ranged from 20 percent to 48 percent.