Lodonal™ is Immune Therapeutics, Inc.’s approved immune modulator for use in emerging nations. Lodonal™, based on the Low Dose Naltrexone formulation, IRT-103/Lodonal™ currently in use with Immune’s wholly owned subsidiary Cytocom, Inc. is designed to offer affordable immune modulation in countries exhibiting the most need for improved health with low cost while developing their own advanced health care systems. Currently, Lodonal™ has received approval in Nigeria following a successful bridging trial.
Clinical Mechanism of Action
Lodonal™ exerts its effects on humans via at least two distinct receptor mechanisms. The first receptor mechanism is the blocking of the opiate receptor for a short period time. This results in a reactive increase in the production of opioid receptors on immune cells, an increase in circulating levels of endorphins and enkephalins. Increased levels of beta-endorphin and enkephalins have been shown to stimulate the immune system, promoting an increase in the number and functions of T lymphocytes and natural killer (NK) cells. The increase in the T-cell and NK cell numbers and functions appears to restore a more normal balance of the immune cells such that effects of disease are significantly reduced.
It has been demonstrated in phase II clinical trials for Crohn’s Disease, HIV/AIDS, Fibromyalgia, MS, Autism and Cancer that in the presence of LDN, the numbers of T-cells, both CD4+ helper T cells and CD8+ cytotoxic T cells, may increase by more than 300%.
In addition to the antagonist effect on mu-opioid and other opioid receptors, naltrexone simultaneously has an antagonist effect on non-opioid receptors (Toll-like receptor 4 or TLR4 or TRL-9 as well as the p receptors) that are found on macrophages such as microglia. In this process IRT-103 is able to shift Th1 to Th2 to reduce inflammation.