Acasti Pharma Inc (NASDAQ:ACST) Will Report Topline Results For TRILOGY 1 Pivotal Phase 3 Trial Of Capre In Early Next Year
Acasti Pharma Inc (NASDAQ:ACST) expects to report topline results of the TRILOGY 1 pivotal Phase 3 trial of CaPre early next year. The drug is used to cure severe hypertriglyceridemia. Acasti has delayed publishing of results of Trilogy 1 because the statistical consultants received the data from the central testing laboratory late. The company regretted the delay because of certain factors outside of its control. It is on track to implement Trilogy 2 study.
Will evaluate the effectiveness of Capre
Acasti will evaluate the effectiveness of Capre in reducing the triglycerides in a 12-week trial. It will also check the tolerability and safety of the drug during the trial. The company will also report secondary endpoints such as VLDL, HDL cholesterol, and Non-HDL cholesterol along with the topline results.
CaPre’s action in diabetes
In the phase 2 trial of 4 gram CaPre that involve humans, the team observed significant reductions in HbA1c. The company is conducting a Trilogy Phase 3 program using the same dosage of the drug in humans. Acastic noted the positive result of HbA1c in COLT, which is unique to CaPre. It is surprising because other therapeutics did not show any impact on glucose metabolism in patients suffering from diabetes.
The company conducted a study on a mouse to know whether CaPre shows any improvement in acting on insulin and/ or glucose. It will compare the outcome with VASCEPA and metformin, a medicine described for the treatment of diabetes. Director of the Pfizer Chair, Dr. Marette, has conducted the study in an animal model for Acasti. In another ongoing study, the company will compare the results of the same drug with an animal suffering from fatty liver disease.
According to the findings of the study conducted on a diabetes mouse, CaPre expects to promote the secretion of insulin. It is a better candidate than metformin, which does not promote insulin secretion. In another test, icosapent ethyl has not shown any improvement in the metabolism of glucose. It has not shown any effect on insulin production. CaPre has improved the production of insulin along with enhanced c-peptide levels. Icosapent ethyl and CaPre have improved plasma 18RS-HEPE significantly.