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 company developing an advanced Omega-3/phospholipid prescription drug called CaPre to treat hypertriglyceridemia (high levels of triglycerides in the blood), which is known to contribute to heart disease.
CaPre has also shown in two Phase 2 clinical trials that it not only effectively reduces triglycerides, but also has the potential to lower LDL or 'bad' cholesterol levels, raise HDL or 'good' cholesterol levels, and lower hemoglobin A1c (HbA1c), which is an important biomarker of long term glucose control in diabetic patients.
Two important Omega-3s found in CaPre are not only responsible for the significant reduction of triglycerides, but also the increase seen in the Phase 2 studies in HDL (good) cholesterol.
In addition, Acasti says CaPre is unique from other Omega-3 drugs in that it also contains phospholipids derived from krill oil. These phospholipids not only significantly enhance the bioavailability and absorption of CaPre, but they are also the reason for the reduction in LDL ('bad') cholesterol and HbA1c in diabetic patients that was reported in the phase 2 studies.
The phospholipids in CaPre act to block the synthesis and absorption of LDL cholesterol, and they also appear to improve the metabolism of glucose in patients with diabetes. The company says none of the competitive Omega-3 therapeutic products on the market or in development can deliver all these important clinical benefits.
Acasti expects to complete the last phase of clinical development of CaPre in patients with severe hypertriglyceridemia, by the end of 2019. There are two Phase 3 studies of CaPre, currently underway, one exclusively in the US, and the other in the U.S., Mexico and Canada.
In total, 500 patients are involved. Topline results from the first trial named TRILOGY 1, are expected to be reported by the end of this year, while topline results for the second trial TRIOLOGY 2, are expected to be reported in January of 2020.
Full data reports for both trials will be available in the first quarter of 2020. Acasti remains on track to file its NDA (new drug application) in mid-2020.
The company plans to commercialize CaPre directly in the US, and through development and commercialization partnerships in other major countries around the world.
Acasti says the initial market potential for CaPre is compelling, since there are between 3 million and 4 million patients in the US alone with severe hypertriglyceridemia.
Third-party outcome studies have also pointed to the importance of lowering triglycerides in around 50 million people in the US who have triglyceride levels above 150mg/dL (mg per deciliter), which represents a significant potential market expansion opportunity for CaPre in the future.
These studies have shown that reducing triglycerides can lead to at least a 25% reduction in cardiovascular events, including death. However, only about 10% of people with elevated triglycerides are receiving treatment. Consequently, physicians and market experts reckon the hypertriglyceridemia market could grow significantly over the next several years.
- Hypertriglyceridemia is a major cause of heart disease, which in turn is the No 1 killer in the US.
- Cardiovascular outcome trials have shown that reducing triglycerides reduces cardiovascular risk by more than 25%.
- Huge opportunity exists globally for omega-3 therapeutics, which are very effective at reducing triglycerides and yet are very safe. This $2.5B global market is now poised to grow significantly over the next five years.
- Acasti’s omega-3 drug CaPre, not only reduces triglycerides, but in phase 2 studies it also showed a positive effect on the major blood lipids (LDL, HDL and non-HDL cholesterol) and HbA1c. This 'Trifecta effect' is clinically valuable, as many patients with high triglycerides also have diabetes.
- The company is nearing completion of its Phase 3 clinical studies, which are designed to confirm CaPre’s “Trifecta Effect”.
- The company says there are currently only two branded competitors, and if CaPre achieves its targeted endpoints in its phase 3 studies, it could become the “best-in-class” therapy for hypertriglyceridemia.
- Discusssions are ongoing with multiple potential strategic partners around the world for licensing and commercialization rights.
- The company is well-funded beyond the completion of Phase 3
Latest news from Acasti
In February this year, Acasti said it believed that its $47.9 million in net proceeds from public offerings, together with existing cash, was adequate to support its operations beyond completion of the Phase 3 clinical trials.
In May this year, Acasti 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.
In total, the company has about 30 patents in the U.S. and around the world that provide very broad IP protection.
"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 are very, very good at lowering triglycerides. They're very potent, but they don't have side-effects. I think what you're seeing now, especially with the recent outcome data that shows that these Omega-3s can significantly reduce heart disease, is more and more physicians prescribing these Omega-3s," said CEO Jan D'Alvise.
"The market now in the United States is roughly US$1.4 billion and is expected to grow significantly. This market in the future could be as big as the statin market which approached US$20 billion."
She added: "Historically, high triglycerides has been an undertreated problem and it's 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 LDL cholesterol."