Our proprietary product pipeline is focused on developing new or improved therapeutics which utilize lipophilic Active Pharmaceutical Ingredients (APIs). Lipids are naturally occurring molecules that include fatty acids, steroids (including hormones), fat-soluble vitamins (such as vitamins A, D, E, and K), monoglycerides, diglycerides and triglycerides, whose principal roles in the body are storing energy, signaling, and acting as structural components of cell membranes. Imbalances of lipids and lipid disorders are currently linked to numerous diseases. However, the ability to treat these imbalances and disorders have been limited based on the fact that lipids, by themselves, are not readily bioavailable and must be taken with food in order to efficiently pass through the intestinal lining.
We believe that, based upon available scientific studies, currently available treatments of lipid disorders and their related diseases are inconsistently absorbed and bioavailable and are impacted by the presence or absence of food in the digestive tract, resulting in inconsistent product efficacy. We believe that our product candidates, which are lipid-based APIs formulated using our proprietary Advanced Lipid Technologies® (ALT®) platform, will be more bioavailable and consistently absorbed than existing conventional formulations, potentially improving efficacy and lowering effective doses. Furthermore, we believe that increased consistency and bioavailability of the lipophilic APIs may facilitate the use of these lipophilic APIs for the treatment of diseases and disorders for which there is no current treatment or for which the currently available treatments have significant side effects.
Our research and development efforts have primarily concentrated on the development of formulations of product candidates based on certain essential fatty acids. We believe these products, when formulated with ALT®, will be more effective in the treatment of lipid disorders and their related diseases than what is currently available in the market and may treat disorders where no treatment currently exists. All of our pipeline products contain fatty acids, in the form of fatty acid ethyl esters, in complex mixtures that differ in the volume of fatty acids included in each dose, the dosage size and form, the blend of surfactants and the ratio of drug to surfactants The surfactants are pharmaceutical excipients selected for their bioavailability and are optimized in a specific ratio to the fatty acids included in the relevant product candidate to enhance the formulation of micelles using ALT®.