Acasti Pharma has global ambitions for its CaPre Omega-3 therapeutic to treat heart disease

• Biopharma group seeking to commercialize innovative CaPre Omega-3 drug to treat heart disease and diabetes

• Well-funded with an advanced candidate in Phase 3 trial, expected to be completed before year-end

• Huge potential market in the US and beyond, which is expected to grow

Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) is a biopharma group that is developing an advanced CaPre Omega-3 drug to treat hypertriglyceridemia (high levels of triglycerides), which is a known link to heart disease.

The therapeutic is currently in Phase 3 trials in two studies, one exclusively in the US, and the other in Mexico and Canada. In total, 500 patients are involved. The trials named TRILOGY 1 are expected to be complete by the end of the year, with top-line data due a few weeks later. 

The company was spun out of a group in around 2008 called Neptune Technologies, which was one of the first to develop Krill oil and turn it into dietary supplements, and has been advancing the technology ever since.

CaPre, a potent form of Omega-3, has been shown to reduce triglycerides, but also to lower ‘bad cholesterol’ levels, and raise ‘good cholesterol’ levels via the firm’s studies. The company is also excited to see its effects on diabetics, as the team thinks it helps to metabolize glucose in the blood.

The market potential is compelling, since there are between 3 million and 4 million patients in the US alone with severe hypertriglyceridemia, and the group hopes to commercialize the product in  the US and in other major countries.

How it’s doing

In February this year, Acasti said it believed its $47.9 million in net proceeds from public offerings, together with existing cash, will see its operations beyond completion of the Phase 3 clinical trials.  It will, however, need to raise additional capital to complete the funding of its NDA (new drug application) preparations, and US commercial launch activities, it added

And in  May this year, it told investors it had  bolstered its IP (intellectual property) portfolio, with the receipt of patents related to the development of CaPre in Israel, Mexico and Chile.

The new patents, valid until 2030, relate to the product’s composition and methods of use. This year, a certificate has also been issued by the European patent office, also valid until 2030.

“These patents are adding up and create a picket fence around our technology and product,” co-founder and Chief Operating Officer Pierre Lemieux told Proactive.

What the CEO says

“The great thing about these Omega-3s is they’re very, very  good at lowering triglycerides so they’re very potent but they don’t have side-effects so really I think what you’re seeing now, especially with the recent outcome data  that shows that these Omega-3s can significantly reduce heart disease,  you’re seeing more and more physicians prescribing these Omega-3s,” said CEO Jan D’Alvise.”So the market now in the United States is roughly US$1.5mln and really expected to grow significantly. This market could be as big as the statin market which approached  US$20 billion in the United States.”

She added: “Historically, high triglycerides has been an undertreated problem and so it’s really only been in the last roughly ten years  that data has come out to show physicians that it’s every bit as important to treat triglycerides as cholesterol.”

Story by ProactiveInvestors