Acasti Pharma Inc (NASDAQ:ACST) received a response to its Type C meeting request from the US FDA. The company will conduct a pivotal analysis of TRILOGY2, considering the feedback of the FDA. Acasti needs to conduct additional clinical trials based on the TRILOGY2 study and before applying for NDA.
Additional information on TRILOGY1
Acasti will provide additional details on TRILOGY1 when announcing financial results on June 29, 2020. It will provide further details on the TRILOGY 2 phase 3 study of purified omega-3 phospholipid concentrate – CaPre, which is developed from krill oil. CaPre will be used for the treatment of severe hypertriglyceridemia.
CaPre plays a vital role to reduce the risk of pancreatitis and cardiovascular disease. Omega3s (DHA and EPA) in CaPre are either bound to the phospholipids or free for better absorption in a human body.
According to Acasti, phospholipids developed from krill efficiently transport DHA and EPA compared to EPA and DHA sourced from the fish. The DHA and EPA developed from fish oil are either transported by ethyl esters or triglycerides and require additional digestion before being transported to the bloodstream.
Phospholipids minimize LDL cholesterol synthesis
Phospholipids boost distribution, absorption, and promotes Omega3s metabolism. They will also play an important role in minimizing LDL cholesterol synthesis in the liver and reducing cholesterol absorption. It promotes the secretion of lipids from bile.
CaPre demonstrated a significant reduction in non-HD cholesterol and triglycerides during phase 2 trials in hypertriglyceridemia patients.
CaPre also minimized bad cholesterol or LDL cholesterol in phase 2 clinical studies. By administering a dose of 4 grams, the drug significantly lowered HbA1c because of the combination of phospholipids and omega3. CaPre will also improve glucose metabolism in the long term.
Intellectual Property Office issues notice of allowance
IP office based in Canada issued a notice of allowance to Acasti for a patent related to second composition matter. As a result, Acasti can include claims for a composition comprising DHA and EHA and the solution consisting of a minimum of 50% of phospholipids.
COO and CPO of Acasti, Pierre Lemieux, said the notice of allowance from the Canadian IP for its second composition of matter is based on similar patents issued in Mexico and the US previously. A strong IP portfolio allows the company to move forward with its business strategy of commercializing the formulations.