Acasti Pharma Inc (NASDAQ:ACST) is trading higher in the market, weeks after coming under pressure on posting a net loss of 29 cents a share on revenue of $2,000. The stock was up in the market by more than 100% on the street taking note of the positive CaPre Omega-3 Bridging Study results.
CaPre Positive Results
The stock is now trading at highs of $2.81 a share, close to its 52-week high of $3.66. It now waits to be seen for how long the stock will ride on the positive clinical data for the novel candidate drug CaPre. Sourced from krill oil, the drug is designed to provide health benefits unmatched by other omega-3 treatment option for patients struggling with hypertriglyceridemia.
Hypertriglyceridemia is a metabolic condition that most of the time leads to increased risk of cardiovascular disease and pancreatic disorders. In a four way, cross over, bioavailability study, Acasti says the candidate drug met its Primary objective on the treatment of the condition in 56 healthy volunteers.
When compared to Lovaza a hypertriglyceridemia-approved drug, CaPre was able to curb a further increase in levels of omega-3 fatty acids in patients fed with a high a fat meal. When administered in patients in fasting state the drug demonstrated better bioavailability. The results essentially point to a much higher safety profile for CaPre.
“We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre,” said Jan D’Alvise, president, and CEO of Acasti Pharma
FDA Push
Focus now shifts towards working with the FDA to confirm the pathway needed to optimize the design for a Phase 3 trial of the drug according to the chief executive officer. Phase 3 trial will try to demonstrate the drug’s efficacy levels in patients struggling with severe hypertriglyceridemia.
Acasti Pharma Inc (NASDAQ:ACST) is also exploring strategies needed for the commercial success of the drug in North America, given that the US represents a significant portion of the global hypertriglyceridemia market.
