The Cleveland Clinic will work with Esperion Therapeutics Inc. to develop “good cholesterol” therapies to fight cardiovascular disease.
Privately held biopharmaceutical company Esperion in Plymouth, Mich. — which discovers, develops and commercializes therapies for cardiovascular diseases — announced its “collaborative research agreement” with the Clinic — the nation’s leading heart medical center — on Monday.
A sidebar: Esperion’s founder, president and chief executive, Roger Newton, is a co-inventor of Lipitor, the Pfizer cholesterol-fighting blockbuster, according to AnnArbor.com. Newton started Esperion in 1998, sold it to Pfizer for $1.3 billion in 2004, then restarted the company in 2008 after Pfizer divested it.
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Another sidebar: Cleveland Clinic star cardiologist and drug industry watchdog Dr. Steven Nissen studied Lipitor in the early 2000s when it was owned by Esperion, hailing the drug for slowing the buildup of “bad cholesterol,” also known as low-density lipoprotein or LDL, in artery walls, according to the Cleveland Plain Dealer.
Researchers have long known that the body’s good protein — high-density lipoprotein, or HDL — can win in its fight with LDL. However, producing a drug that raises HDL remains a researcher’s dream.
In 2006, Pfizer halted tests of an HDL-raising drug because of safety concerns, the Plain Dealer reported. Nissen led the study of another HDL-raising drug — a protein known as ApoA-1-Milano — which held great promise to reverse plaque buildup in heart arteries, but was too difficult to make and caused allergic reactions.
“When Esperion was first founded, we collaborated with Cleveland Clinic in a research effort that showed for the first time that HDL can reverse atherosclerosis in acute coronary patients,” Esperion’s Newton said in his company’s release. “The results were published in the Journal of the American Medical Association in 2003.
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“When we re-established Esperion in 2008, our goal was to continue this research tradition,” Newton said. “We are once again bringing together the outstanding resources and expertise at both Esperion and Cleveland Clinic to advance important research efforts in HDL in the years ahead.”
Esperion and the Clinic are aiming at developing new HDL therapies that work and are tolerable to heart disease patients. The leading development candidate is a compound that was discovered at the Cleveland Clinic by research groups led by Jonathan Smith in the Department of Cell Biology at the Clinic’s Lerner Research Institute and Dr. Stanley Hazen, director of the Clinic’s Center for Cardiovascular Diagnostics and Prevention.
“What we’re hoping to do through this partnership with Esperion is to leverage the strengths in both basic and clinical research in atherosclerosis and heart disease at the Cleveland Clinic with Esperion, which has proven leadership in the field of HDL-targeted therapeutics, in terms of migrating this research to a usable human clinical therapy,” Hazen said.
“What we developed was an improved formulation or form of an HDL for treating existing heart disease. Our hope is to use this, not only to retard the progression of the disease in patients with heart disease, but the new and exciting data is that it can effectively promote … removal of cholesterol deposits in the artery wall,” he said.
That means the HDL-raising drug candidate would reverse heart disease.
The new HDL formulation is more potent and has a longer biological half-life than the previous form. “So the need for infusing it should be less often,” Hazen said. “What we now know is, when HDL diffuses into the artery wall to do its beneficial things, it is turned off. This improved HDL will last longer in the artery wall and will be — we hope — a more potent form of therapy.”
Consider it a “genetically engineered and improved form of HDL,” he said.
How soon could the new drug be ready for human consumption? “We think we can have an aggressive time line for getting this into human trials,” Hazen said. “We’re hoping that within one or two years, we’ll be able to be into man in clinical studies.”
If the trials are successful, it would take years for Esperion — which already has experience taking HDL therapies into humans — to commercialize the drug.
The Esperion/Clinic collaboration agreement was developed with help from Cleveland Clinic Innovations, the Clinic’s corporate venturing arm, with commercialization in mind. If successful, Cleveland Clinic Innovations would license the drug to Esperion for commercialization, Hazen said.
It’s an emerging model for drug development. “Big Pharma more and more is putting off the new developments and having biotech develop them,” Hazen said. “Here, we’re talking about academia developing the new discovery or improvement, and then transitioning it to a commercial group that” has the experience and money to develop and market it, he said.
An HDL-related cardiac inflammation biomarker developed by Hazen and his colleagues was the basis for Cleveland Clinic spinoff Cleveland HeartLab last year.
There likely will be more Esperion/Clinic collaborations to follow.
“We have seen over the past decade the potential for HDL therapies to have a positive impact on our ability to treat cardiovascular disease,” Smith said in the Esperion release. “In collaboration with the Esperion team, our goal is to identify the most promising opportunities to use HDL therapy to treat disease and improve human health in the years ahead.”
