Advanced Lipid Technologies® (ALT®) is our exclusive platform that uses cutting-edge development and manufacturing techniques to create drug products that have the ability to increase the consistency with which lipid-based and lipophilic Active Pharmaceutical Ingredients (APIs) are absorbed and used by the body. We believe that our ALT® platform can be applied to various forms of lipophilic APIs in order to increase their effectiveness, enhance the absorption of the products, and improve the availability of existing known lipid-based therapeutic agents. Furthermore, we believe that our exclusive ALT® platform has the potential to be applied to a broad range of health issues and multiple, new therapeutic areas that can benefit from products that enhance the consistent absorption and utilization of lipids in the body.
How ALT® Works and Our Self Micellization Solutions
In order to properly absorb lipid-based APIs in the digestive tract, the lipid particles (fatty acids) must form strong circular bonds called micelles. Normally, the assistance of bile salts and phospholipids is required to ensure proper micelle formation and lipid absorption. The problem that scientists have encountered for decades when attempting to deliver lipophilic drugs is that the body only releases these substances into the digestive tract in the presence of high fat meal. Previous attempts to create artificial micelles have generally resulted in fatty acid bonds that are fragile and easily broken, making it difficult for adequate amounts of free fatty acids and monoglycerides to be absorbed into the intestinal wall and passed into the bloodstream.
Our unique and exclusive ALT® platform focuses on spontaneously and effectively creating engineered micelles that overcome the limitations of both artificial and natural human micelles in the delivery of fatty acids. This results in maximum absorption of fat-dissolvable APIs under almost any condition, whether or not food is present. The engineered micelles are always uniform in size and are able to carry their cargo of drugs (or fat-dissolvable materials) to and through the intestinal wall, without the assistance of bile salts, thereby enhancing absorption of the drug. The graphics below demonstrate how micelles formed with the ALT® platform can assist the body in absorbing lipids without having to rely on the presence of food.
Our Current Product Candidates Formulated with our ALT® Platform
Each of our product candidates is made up of an exclusive and customized mixture of fatty acids, including omega-3 fatty acids, and at least one surface active agent, which is a substance that promotes the proper formation of the fatty acids in the products being developed. In particular, the surface active agents help ensure that the fatty acids and monoglycerides will form strong circular bonds called micelles through the use of the ALT® platform. Drug compounds that are developed with our ALT® platform are designed to be absorbed without the need for the patient to take the drug with a high-fat meal. As a result, micelles are formed when the products come into contact with digestive fluids and remain stable until they cross the intestinal wall and enter the bloodstream, whether or not food is present in the body. Furthermore, these factors should allow lower and/or less frequent dosing, as few as one to two capsules a day, and this eliminates the pill burden, the harsh aftertaste, unpleasant smells, and burping that is typically associated with the currently available treatment options.
Future Potential Applications of our ALT® Platform
Over the past decades, many new lipophilic compounds have not been developed into drugs because of the challenges associated with maximum absorption of lipid-based active pharmaceutical ingredients (APIs) by the body. Instead, when a promising new drug was found to be lipophilic, efforts were directed toward changing the characteristics of the drug to one that was hydrophilic (water soluble). This is achieved by creating salt forms of drugs or various esters (alcohol-containing compounds). In other cases, the development of potential fat-soluble drugs was simply discontinued because, due to absorption difficulties, the lowest effective dose was impractical. In addition, there are many lipophilic drugs currently on the market that have significant effects in the presence of food or are poorly absorbed. We believe that we may be able to increase the absorption of these types of fat-soluble drugs through the application of our ALT® platform, thereby potentially reducing the currently recommended doses to more practical levels and reducing side effects. This process would make it possible to continue developing such products.
We believe that our exclusive ALT® platform has the potential to be applied to a broad range of health issues and multiple, new therapeutic areas in which lipophilic substances can be used to treat conditions including, but not limited to: epilepsy, attention deficit hyperactivity disorder (ADHD), age-related macular degeneration, Barrett’s syndrome, bipolar disorder, dementia, fibrotic diseases, hormone “mono and combination” therapies, traumatic brain injury (TBI) and peripheral neuropathy.