Tuesday, 13 August 2013

Acasti Releases Statistically Significant Phase II Data

Acasti Pharma
Shares Outstanding: 79.4 million
Fully Diluted: 91.4 million

“This is excellent data: we clearly have the best in class fish oil drug; based on the LDL and HDL effects, we even appear to have something quite special,” says Hugh Cleland, Portfolio Manager at BluMont Capital.

The study had a patient population of over 230 patients, who took 4 grams of Capre for 8 weeks. 88% of the patients were "mild-to-moderate" hypertriglyceridemia or the “harder-to-treat population.”

The results:
·         A decline of 21.6% in triglycerides (goal was 20% or more)
·         A decline of 8.3% in LDL (and a decrease in non-HDL cholesterol of 14.3%)
·         An increase of 11.1% in HDL. 
·         Capre was shown to be safe and tolerable, resulting in no serious adverse events.

According to Dr. Harlan Waksal, Executive Vice President for Acasti, “This harder-to-treat population represents over 40 million people in the U.S.A., for which no Omega-3 prescription drug has yet been approved by the U.S. Food and Drug Administration (FDA). These results can also indicate that CaPre could be as efficient, if not even more successful, in treating patients with baseline triglycerides above 500mg/dL.”

The double-blind, placebo-controlled phase II results are expected by the end of the first half of 2014. These results will include Capre’s effects on patients with >500mg/dL triglycerides.

Those results, will allow investors to directly compare Capre to the various pharma grade fish oil drugs. The results that the other fish oil drugs (Lovaza, Vascepa, Omthera's) caused were as follows:

To view today’s news release, please click here.