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Acasti Pharma eyeing FDA meeting as it continues to advance heart disease candidate CaPre

Snapshot

A pre-clinical mouse study last year of the drug also offered new insights into a potential mechanism of action in type 2 diabetes

Acasti Pharma Inc -

Quick facts: Acasti Pharma Inc

Price: 0.35 CAD

TSX-V:ACST
Market: TSX-V
Market Cap: $33.91 m
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  • Seeking to commercialize CaPre, a krill-oil derived prescription drug
  • Drug has other clinical benefits possibly for diabetic patients
  • Huge potential market in the US and beyond

What Acasti Pharma does:

Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) is developing a krill-oil derived prescription drug called CaPre to treat hypertriglyceridemia (high levels of triglycerides in the blood), which is known to contribute to heart disease.

In Phase 2 trials, CaPre has also shown 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) - an important biomarker of long term glucose control in diabetic patients.

A pre-clinical mouse study last year of the drug offered new insights into a potential mechanism of action in type 2 diabetes, which is unique from its counterparts.

The study showed that CaPre may promote insulin secretion, according to a standard glucose challenge test, which measures the body’s response to sugar.

Acasti also 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 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.

How is it doing:

The last phase of clinical development of CaPre in patients with severe hypertriglyceridemia saw two Phase 3 studies and 500 patients involved. The first trial - TRILOGY 1 - was exclusively in the US, while TRILOGY 2 was carried in sites in the US, Mexico and Canada.

In January this year, Acasti reported that further analysis was underway after topline results from the TRILOGY 1 trial for CaPre did not reach statistical significance due to an unusually large placebo effect.

In February, the firm updated further, saying that a “detailed examination” of the Phase 3 TRILOGY 1 results for CaPre was underway in specific clinical site audits and an audit of the central testing lab.

In TRILOGY 1, five sites out of the total 54 enrolling sites disproportionately contributed to the unusual placebo response - or 36% of the 242 patients enrolled in the study.

By comparison, TRILOGY 2 was conducted at 71 sites in Canada, Mexico and the US that enrolled a total of 278 patients. The same five sites also participated in TRILOGY 2, however, these only accounted for 12% of total patients, with the majority of these patients coming from only three sites.

Acasti said it had identified some “unexpected and inconsistent findings” in the TRILOGY 1 trial that it believes may have negatively contributed to the overall topline results.

Acasti said it will request a meeting with the US Food & Drug Administration (FDA) to discuss the TRILOGY 1 data, and will thus also seek its guidance on how to conduct the analysis of the TRILOGY 2 data prior to unblinding.

Given the need to complete the TRILOGY 1 data audit, and get FDA feedback, the company now expects the unblinding of topline results for TRILOGY 2 in the third quarter.

In November last year, the firm announced a significant breakthrough in its journey towards a commercial launch for CaPre, as it revealed it would partner with Norwegian group Aker BioMarine for a two-year supply of krill oil, its main ingredient. Notably, the agreement includes a fixed-price, securing an adequate supply to Acasti of raw krill oil through to at least mid-2021.

If Acasti gets FDA approval for CaPre, it will be the only drug company using such an amount of the oil to make a drug, so it's a big deal for both firms.

Discussions are ongoing with multiple potential strategic partners around the world for licensing and commercialization rights and Acasti is well-funded beyond the completion of Phase 3.

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.

In March, the company said it had won a fourth patent in the  USA plus a third patent in Mexico, strengthening the intellectual property (IP) case for CaPre.

What the broker says:

In November last year, healthcare-focused research firm Encode Ideas kicked off coverage of Acasti as a 'high-risk' investment idea.

"The theoretical timing of a CaPre launch in 2021 is ideal, with the Omega-3 market thriving due to the likely label expansion for Amarin’s Vascepa, based on the compelling REDUCE-IT study, and the possible commercial launch of AstraZeneca’s Epanova," Encode's analysts said in a research note.

"Even with an inferior label relative to Vascepa, and likely Epanova, we believe that CaPre can carve out a niche in what should be a vibrant omega-3 market," they added.

What the boss says:

Jan D’Alvise, Acasti CEO told investors: “We have completed the clinical site and central lab audits of the TRILOGY 1 data, including additional post-hoc analyses. As a result, I am pleased to report that we now expect to submit our FDA meeting request by the end of March. We look forward to reporting further developments, including an update on a meeting date as soon as it has been set.”

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Full interview: Acasti has 'put its finger on something very interesting' in...

Acasti Pharma Inc (NASDAQ:ACST)(CVE:ACST) COO Pierre Lemieux tells Proactive the last patient completed their final visit in its TRILOGY 1 trial of lead drug CaPre, which treats severe hypertriglyceridemia. Lemieux says the Quebec-based company is on its way to reporting results by the end of...

on 26/11/19

5 min read