Rheumatoid Arthritis, RA, is an auto-immune disease where the immune system is unable to differentiate foreign cells from its own and produces antibodies to connective tissue causing a range of symptoms including pain, swelling and destruction in the joints. Current treatments for RA involve multiple classes of drugs including: antimetabolites (methotrexate); biologic response modifiers (Remicade®, Humira®, Enbre®l, Rituxan®); corticosteroids (prednisone); non-steroidal anti-inflammatory drugs (Ibuprofen, Naprosyn, Indomethacin); COX-2 inhibitors (Vioxx®, Celebrex®, Bextra®); disease modifying antirheumatic drugs (Plaquenil®, Arava®); and salycilates (aspirin). Overall these therapies are often ineffective, expensive to produce and inconvenient to deliver (via injection). Recently Vioxx (COX-2 inhibitor) has been withdrawn from the market. The most directly competitive orally available small molecule treatment for RA is methotrexate (generic) which has significant toxicities and limited efficacy in RA.
Worldwide over 29 million people have RA with over 2 million in the US.
Nuon Therapeutics, Inc.'s lead program addresses the clear unmet need for an effective oral agent to address Rheumatoid Arthritis. Based upon preclinical studies, Tranilast, a small-molecule, orally available drug, has shown efficacy in industry standard preclinical animal models of RA in mice (Collagen Induced Arthritis model). In these studies, Tranilast has been evaluated using multiple endpoints and compared with positive controls demonstrating superiority in most applications to class leading compounds. In these studies, Tranilast showed efficacy in reversing established disease and dramatically improved symptoms at plasma levels lower than those seen in human clinical trials. Nuon Therapeutics, Inc. anticipates starting worldwide clinical trials in early 2008.