Acasti Pharma Inc (CVE:ACST) (NASDAQ:ACST) said it is on track to report topline results from the first phase of clinical trials on its CaPre prescription drug candidate by the end of the year, with phase two due early in 2020.
The news came as the company released fiscal first quarter results Wednesday that highlighted a number of recent developments in the biopharmaceutical company’s quest to put CaPre on the market to combat severe hypertriglyceridemia.
CaPre is an omega-3 phospholipid concentrate derived from krill oil. The new treatment is currently being tested in the third phase of the TRILOGY clinical trials.
READ: Acasti Pharma reiterated as Speculative Buy by Mackie after FDA setback news for competitor Amarin
Both Phase 1 and 2 TRILOGY studies achieved 100% patient randomization, and 68% of the patients have now completed their 6-month plan, Acasti told investors. The Laval, Quebec-based company expects Phase 1 results to be released by December 2019 followed by Phase 2 in January 2020.
Acasti CEO Jan D’Alvise said in a statement that the company is “eagerly” awaiting the completion of the results from the two TRILOGY clinical studies.
“These trials showed not only a significant reduction of triglycerides, but 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,” D’Alvise said.
“As previously disclosed, we believe our Phase 3 trial is well designed to meet our primary endpoint due to the fact the patients enrolled have higher baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl.”
CaPre "attractive alternative"
D’Alvise told investors that the patients randomized to CaPre in TRILOGY all received 4 grams per day and will remain on the drug for 6 months. Phase 2 studies included patients receiving a range of doses between 1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks, which is important given the favorable dose response the company saw in Phase 2 studies.
“Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to provide an attractive alternative to current therapies, and thus improve the lives of the millions of patients with cardiometabolic disease,” D’Alvise said.
The company reported C$25.4 million in cash at the end of June, enough to fund operations beyond Phase 3 trials, it said. The cash will also support US commercial launch activities and fund work on the New Drug Application (NDA).
For the quarter ended June 30, 2019, the company reported a net loss of C$11.8 million or C$0.15 per share, compared to a loss of C$7.4 million or C$0.23 per share during the same period last year. The higher net loss was attributed to the formation of the commercial leadership team during the second quarter of fiscal year 2019 to support expanded business and market development activities.
Last week research firm Mackie Research reiterated a Speculative Buy rating on Acasti’s stock after its main competitor Amarin received a setback on approval for its Vascepa heart drug. The firm set a price target of C$8.70 on the stock.
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