Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) told shareholders that it remains on track to report topline results from its TRILOGY studies of lead drug CaPre within the next two months, a key catalyst in the pharmaceutical company’s path to commercialization.
CaPre is a purified omega-3 concentrate derived from krill oil being developed to treat severe hypertriglyceridemia (HTG).
Assuming study results are positive, Acasti intends to file an NDA by mid-2020 to obtain regulatory approval for the drug in the US, initially for the treatment of severe HTG. The Laval, Quebec-based company said it hopes to launch CaPre in the US by the second half of 2021.
READ: Acasti Pharma says independent study highlights effectiveness of CaPre in treating hypertriglyceridemia
Jan D’Alvise, Acasti’s CEO, said that the company is “eagerly awaiting” the completion of the results from its two TRILOGY clinical studies because initial indications from the Phase 2 and 3 trials appear promising.
D’Alvise told shareholders that the large patient population in Phase 2 trials (675 patients) demonstrated both a significant reduction of triglycerides and also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C, as well as HbA1c in patients with diabetes.
As well, patients enrolled in Acasti’s Phase 3 trials have higher baseline triglyceride levels versus Phase 2 studies, where most had baseline triglycerides significantly below 500 milligrams per deciliter in the blood.
D’Alvise also said that a favorable dose response was reported in the Phase 2 studies, in which patients received a range of doses that the company believes bodes well for Phase 3 trials.
The CEO said the fact that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C is known as the “Trifecta Effect.”
“Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to become a best-in-class omega-3, due to both the Trifecta Effect and greater bioavailability, especially in patients that follow the standard physician-recommended, restricted low-fat diet,” D’Alvise said.
“We believe these benefits are due to our unique composition of phospholipids, EPA and DHA as compared to ‘esterified’ pharmaceutical omega-3s derived from fish oils. Additionally, in all studies conducted to date, CaPre has shown no negative side effects or safety concerns.”
READ: Acasti Pharma inks krill oil supply deal with Aker BioMarine to scale up production of its drug candidate CaPre
The company is also ramping up its commercialization efforts, including a supply agreement with Aker BioMarine to provide raw krill oil to Acasti under a two-year, fixed-price supply agreement. D’Alvise said the company believes the agreement will ensure an adequate raw material supply to meet its anticipated needs through at least mid-2021, including scale-up of production to build future inventory for anticipated commercial launch.
The CEO said Acasti is also in discussions with a number of pharmaceutical companies regarding potential commercialization partnerships in several countries around the world.
According to its second-quarter results released Wednesday, Acasti posted a net loss of C$28.3 million or C$0.34 per share. It ended the period with C$25.8 million in cash, mainly generated by the proceeds of public offerings and warrant exercises.
Mackie bullish on stock
In a note on Wednesday, Mackie Research Corporation analyst Andre Uddin wrote he is expecting ACST to have a “good run” ahead of the TRILOGY results.
“We believe Acasti is undervalued with a market cap of below US$200 million,” Uddin wrote.
The analyst drew comparisons between Acasti and biopharmaceutical company Amarin Corporation, which had a market cap of over US$360 million immediately before it reported Phase 3 results for its omega-3 fatty acid Vascepa in 2010.
Mackie maintained a Speculative Buy rating and C$8.70 target price on Acasti’s stock.
Shares of Acasti traded at C$2.74 in Canada and US$2.07 in the US by early Wednesday afternoon.
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