A Wilmington-headquartered specialty pharmaceutical company is on a mission to broaden the potential applications for its flagship product, a cardiovascular polypill. 

Founded in 2007, CardioPharma is reviewing proposals from researchers seeking to study the non-cardiovascular benefits of cardiovascular polypills, which combine multiple heart medications into a single dose. 

Daniel Gregory, co-founder of the company, said that the motivation behind developing a polypill – or a fixed-dose combination drug –  is to address cardiovascular disease, the leading cause of death in the world, more efficiently.  

“There are some reasonably simple things you can do for (cardiovascular disease),” Gregory said. “The No. 1 problem we generally see in medicine is ‘adherence.’ People simply don't take their pills like they're supposed to.”

“If you simply take the standard care medicines and put them into one pill, it makes it significantly easier,” he added. 

Gregory said the other co-founders of the company – Roy Stimits, Frank Snyder and Wayne Whittingham – met while working for contract research organizations in Wilmington. 

CardioPharma’s flagship product, CardiaPill, combines three cardiovascular drugs: a cholesterol-modifying agent, an antihypertensive and an antiplatelet drug. Combining multiple medications into a single dose improves adherence and is a much more cost-effective alternative, Gregory said. 

"We're working to bring this to market as fast as possible at an extraordinarily low cost,” said Gregory. “That's our goal."

CardiaPill has completed key pharmacokinetic trials and is now in late-stage development. The company has submitted exhibit batches of the drug in the U.S. and is finalizing large-scale manufacturing partnerships and regulatory submissions abroad. CardioPharma has also received a Special Protocol Assessment from the FDA, which provides guidance on clinical trial design. 

"It is getting closer by the month to getting on the market,” Gregory said. 

Most recently, CardioPharma announced plans to fund secondary analyses of existing datasets exploring the non-cardiovascular benefits of on-the-market cardiovascular polypills, including potential effects on Alzheimer’s disease, stroke risk, chronic kidney disease and cognitive decline. 

Instead of conducting new clinical research, the analyses will examine existing longitudinal datasets – an approach Gregory said will save both time and money.

"They're going to take existing data that's already out there,” Gregory said. “If they look at it longitudinally over years, likely decades... ideally they can come up with a trend."

As part of the project, CardioPharma has already received proposals from research institutes around the world. The company plans to announce proposal winners in June and will offer research funding up to $30,000.  

"Based on the impressive proposals received, we are excited about the opportunity to expand the medical literature beyond the traditional benefits of cardiovascular polypills," said Snyder, chief medical officer of CardioPharma, in a news release. 

CardioPharma is funded mainly by private investors, Gregory said, with support coming primarily from regional investors and funds outside the United States. 

While CardioPharma’s target market is North America, Gregory said there has been strong interest from parties in the Middle East and sub-Saharan Africa, where access to cardiovascular treatment may be more limited. 

"Particularly in the developing world, a polypill like this is safe and inexpensive enough and standard-of-care enough that it could be provided to also minimize disease in those countries,” he said. 

“There are dozens of articles published each quarter in the medical literature, expanding upon the wonderful benefits of cardiovascular polypills,” he added. “But the gross lack of availability around the world is very disheartening.”