Even with significant educational efforts, heart disease remains the leading cause of death in the US and worldwide—for both men and women. While statins are the standard of care, Esperion Therapeutics is focusing on the approximately 30% of patients who either cannot take statins at all or at doses needed to control their LDL-cholesterol. “At Esperion, we are commercializing impactful products to support medical professionals with patients who are statin intolerant. Research shows an estimated 29% of patients stop their statin within the first year. There can be a variety of reasons people stop taking a statin including muscular side effects, however, we know uncontrolled LDL-cholesterol puts these individuals at risk for heart attacks or other cardiovascular procedures such as stents,” said Koenig.

The company is offering a variety of educational tools for both healthcare providers and patients to raise awareness about statin intolerance and alternative treatments. Patient materials are available at statinalternatives.info.

Guidelines Support Non-Statin Therapy

Recently the European Society of Cardiology published an update on its 2019 guidelines for the management of dyslipidemias. “The updated guidelines suggest, similar to the management of hypertension or diabetes, that an approach with combination of LDL-C lowering therapies is needed earlier in treatment.” Koenig noted.

“We are pleased to report that in the updated European guidelines bempedoic acid received a class 1A recommendation in those patients who cannot take a statin or can take a statin and are at high risk. This is one of the highest recommendations you can receive. So, whether you can or cannot take a statin, you can use bempedoic acid. They actually attributed one complete section to bempedoic acid in the guidelines. It was the only new LDL-C lowering agent to be mentioned.”

“It is too early to tell how the pickup will be in Europe because of this update but we are encouraged,” Koenig added.

The American College of Cardiology (ACC) is currently reviewing its guidelines and an update is anticipated in the first quarter of 2026. Esperion is anticipating a similar positive evaluation of bempedoic acid in the updated ACC guidelines and the company is already preparing educational materials for both healthcare providers and patients.

Exploring New Therapeutic Areas

With confidence for the future of bempedoic acid, the company has turned its attention to advancing its expertise with ACLY biology into a new disease category.

“On April 24 of this year, Esperion held an R&D Day where we announced the development of a lead compound for Primary Sclerosing Cholangitis (PSC), which is a very rare orphan liver disease,” Koenig said. “There are at least 72,000 patients who suffer from this difficult-to-diagnose disease worldwide. Typically, once diagnosed with PSC you’re typically looking at a liver transplant in one to two decades with no approved therapies to cure or halt PSC progression.”

Koenig points out that this investigational candidate is not bempedoic acid. “This is a completely different drug with its own intellectual property and we own the global rights. PSC is the start of what could be an entire liver program with the potential to also investigate diseases of the kidney in the future.

“We believe we have the potential for the first medication that will help treat and potentially reverse PSC. However, a lot remains to be done. We’ve passed all the screenings necessary to move forward, and we anticipate filing our IND next year and going into clinic soon thereafter,” Koenig explained.

“We will have to wait and see what happens with humans,” Koenig added. “But it’s very promising.”

A Clear Vision for the Future

Esperion is developing an internal initiative titled Vision 2040 to define the company’s strategy moving forward and bring together employees under this shared vision throughout all areas of the organization.

“We are in business to develop life-saving medications for patients and their healthcare providers,” Koenig explained. “Ultimately, that all comes down to everyone at Esperion understanding and advancing our vision every day. We have the people in place and through Vision 2040, we will have the plan to realize our goals.”