AlphaCore Pharma is ready to begin a phase 1 clinical trial to evaluate the safety and tolerability of its protein therapeutic agent intended to remove cholesterol from tissues and circulating cells in patients with coronary artery disease.
Conducted at the National Institutes of Health, the study will produce results by the third quarter, according to AlphaCore’s acting head of business development William Binkerhoff.
The injectable drug ACP-501 contains the enzyme lecithin: cholesterol acyltransferase (LCAT), which helps facilitate cholesterol transport and removal from the body through reverse cholesterol transport. Atherosclerosis from plaque buildup on the walls of the arteries is the principal cause of coronary artery disease.
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“This protein has been recognized as an important component for cholesterol metabolism, but it’s never been developed as a therapeutic,” Binkerhoff said.
Cholesterol-lowering drugs comprise a $34 billion global market, and at least a handful of other companies are also hoping to penetrate this market over the next several years. Binkerhoff said that other companies, including Esperion Therapeutics, Cerenis Therapeutics and CSL Behring, working with the reverse cholesterol transport pathway are taking a different approach from AlphaCore, and instead are developing HDL mimetics.
In addition to treating coronary artery disease, the drug has potential use in the treatment of heart attacks, certain types of anemia and other disorders, according to the company. In 2010, the U.S. Food and Drug Administration granted it orphan drug designation for treatment in patients with LCAT deficiency.
Ann Arbor, Michigan-based AlphaCore was formed after Pfizer closed its Ann Arbor campus in 2007 and the FDA approved its investigational new drug application in October.
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Binkerhoff said AlphaCore is now actively searching for partners and venture backing to bring the drug through clinical proof of concept.