Inflammatory and Immune

Inflammatory and immune diseases occur in many different forms and range in severity from inconvenient and irritating to debilitating and life threatening. Common conditions involving immune system dysfunction include diabetes, allergies, rheumatoid arthritis (RA), immune deficiency disorders, inflammatory bowel disease (e.g., IBD, Crohn’s, ulcerative colitis), lupus, graft-versus-host disease (GvHD), dermatological conditions (e.g., psoriasis, eczema), pelvic inflammatory disease, pulmonary conditions, scleroderma, transplant rejection, vasculitis and a range of others. According to the National Institutes of Health, there are more than 80 different recognized types of autoimmune disease. Collectively, these conditions affect many millions of individuals in the United States and the rest of the world and represent a substantial healthcare and socioeconomic burden.

Inflammatory and immune conditions are caused by an acute or chronic imbalance in the immune system. In these conditions, cells of the immune system begin to attack certain tissues or organs in the body, resulting in tissue damage and loss of function. Some inflammatory and immune conditions are associated with age-related conditions (e.g., rheumatoid arthritis), but some are due to other causes that may be genetic, environmental or a combination of both (e.g., Type 1 diabetes, IBD). Still other conditions may reflect complications associated with the treatment of other conditions (e.g., GvHD, a frequent complication associated with transplant procedures used to treat leukemia or related blood-borne cancers). Each of these conditions shares certain biological characteristics, in that the immune system imbalance results from the inappropriate activation of certain populations of immune cells that subsequently results in significant tissue damage and destruction. This immune imbalance may result in a complex cascade of inflammation that can result in pain, progressive tissue deterioration and loss of function. While currently available immunomodulatory drugs have proven to be effective for many patients, they have failed to adequately address the needs of many other patients that suffer from inflammatory and immune disorders.

Just as there are a broad spectrum of different diseases and conditions involving the immune system, there are a wide range of different therapeutic approaches that have been developed to address these conditions, including commonly utilized non-steroidal anti-inflammatories (NSAIDs), corticosteroids, immunosuppressive drugs (e.g., cyclosporine, cyclophosphamide, prednisolone, tacrolimus), biologics (e.g., IFN-β, anti-TNFα therapies) and others. Despite the range of therapies currently available, treatments that are consistently safe and effective are lacking for many indications, and many become less effective or ineffective after prolonged use. There is no recognized cure for chronic autoimmune disease.