RA is a debilitating disease of joints in which the body’s immune system generates an inflammatory response causing partial to complete immobility and inflammation of joints & organs. Flexible joints are severely affected leading to burning and severe pain. Thus, RA patients exhibit swollen joints, pannus, cartilage loss, bone damage, and eventual loss of mobility as a result. In disease, inflammatory cells host themselves in synovial joints causing further damage to the joint cavity enhancing disease pathology which slowly deteriorates the joints.
For the last two decades, anti-TNF therapies have captured the market. Given the large market size, each one has penetrated the market with a share of ~25% ($12 billion) leaving only 25% of the market for other drugs. Although anti-TNF therapies are very effective, they have serious side effects. All anti-TNF treatments, regardless of the maker, have FDA Black Box Warning labels on the products.
NovelMed has developed a unique monoclonal antibody portfolio that prevents the formation of a multitude of inflammatory mediators involved in RA from a therapeutic standpoint. This humanized product's unique mechanism of action prevents inflammation and joint destruction, and improves joint mobility. Such products are not expected to cause Black Box Warnings.
Our strategy is to prevent the formation of multiple inflammatory mediators through the inhibition of the unique pathway for all, instead of individually neutralizing each inflammatory mediator. Our preclinical studies in animal models suggest that our neutralizing therapeutic antibodies could provide disease-modifying benefits to RA patients through:
The total RA market is estimated to be $12-13 billion worldwide and rising with an aging and longer-living population. Based on its unique mechanism of action, the drug product is expected to have a transformational effect on the lives of millions of people worldwide. Additional target clinical indications for this drug are Gout, Crohn’s disease, Inflammatory Bowl Disease (IBD), and Juvenile Idiopathic Arthritis.