Severe Hypertriglyceridemia – SC401

Very high circulating triglyceride levels have been linked to pancreatitis. Levels above 500 mg/dl have also been linked to cardiovascular disease and liver disorders. Levels between 300 – 500 mg/dl are currently being studied in cardiovascular disease-focused trials.

There are over 3.4 million Americans suffering from severe hypertriglyceridemia. The current US market for Lovaza®, Vescepa® and generic versions exceeds $500,000,000.

Treatment options include fibrates, statins, and several Omega-3 fatty acid products. In all cases, mild to severe side effect profiles or extremely large doses create compliance issues. The current dose of fatty acids used to treat this disease is 4,000 mg/day. The existence of a major food effect and poor bioavailability have contributed to the poor compliance and variable efficacy.

Problem: Approved treatments require mega-dose levels of essential fatty acids and have broad side effect profiles.

Current Treatment: There are three approved Omega-3 therapies available, all requiring 4,000 mg/day dosing. Fibrates and Statins are also used to treat this disease but with significant side effects.

ALT® Solution: An ALT super bioavailable formulation has been shown to reduce triglycerides by over 40% with a lower dose of Omega-3 fatty acid formulation within 14 days. The formulation can be taken with or without food.