Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) noted a number of successful new developments related to its ongoing Phase 3 clinical trials of its flagship drug CaPre, an omega-3 phospholipid to combat high levels of triglycerides, or fatty molecules.
The Laval, Quebec-based company said it was well-funded to complete Phase 3 trials of the drug that treats hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Initial results from the trials are expected in December 2019.
Investors sent shares of Acasti higher in Wednesday's trading in New York, up 18.6% at US$1.25. In Toronto, shares rose 12.7% at C$1.60.
CEO Jan D’Alvise said fiscal 2019 was an “eventful” year for Acasti, which recently announced that it had achieved 100% patient randomization in both TRILOGY clinical studies, and more than 60% of patients have now completed the trial.
“As a result, we remain on track to report topline results for our primary endpoint of lowering triglycerides for TRILOGY 1 in December 2019, and for TRILOGY 2 in January 2020,” D’Alvise said in a statement.
D’Alvise also said that Acasti will aim to present the full data set at the American College of Cardiology meeting at the end of March 2020.
Acasti plans to submit a New Drug Application to the US Food and Drug Administration by mid-2020 assuming Phase 3 is successful. The company is also in discussions with major pharmaceutical companies for global commercialization partnerships, it said in a statement.
The pharmaceutical company had C$34.4 million in cash, cash equivalents and marketable securities at the end of March 2019, enough to fund activities beyond Phase 3 clinical trials. The company also reported a higher net loss for the year due to a planned C$24 million increase in research and development expenses for the Phase 3 trials.
Acasti recently announced that it was awarded a second patent in China, a key market for the pharmaceutical company.
Since the beginning of 2019, Acasti was granted patents in numerous European countries as well as Mexico, Chile and Israel.
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