Small Molecule TNF-alpha Inhibitor for the Treatment of Arthritis

Period of Performance: 08/01/2009 - 07/31/2011


Phase 1 SBIR

Recipient Firm

Novelmed Therapeutics, Inc.
Cleveland, OH 44106
Principal Investigator


DESCRIPTION (provided by applicant): Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with joint inflammation, destruction, deformities, and increased mortality rates that affect 1.3 million Americans. Current approaches for treating RA are inadequate in preventing the devastating inflammation and joint destruction that result from RA. Current therapies target tumor necrosis factor alpha (TNF-1). Remicade is an anti-TNF-1 antibody and Enbrel is a sTNF-1 receptor. Both drugs are very expensive and given intravenously, and do not cure the disease. These drugs do not prevent the production of excessive TNF-1 and thus can only halt the progression of the disease when given to patients. If patients stop taking the drug, their condition deteriorates. Due to the cost of these drugs, only a high income group can gain access to treatment. NovelMed has identified, through small molecule screening, a potent inhibitor of TNF-1 production, which we designated as NM2014. The molecule inhibits inflammation and joint damage in a rat model of adjuvant-induced arthritis. We propose to evaluate its efficacy in rat AIA and mouse collagen-induced arthritis models of RA. In phase II, we would like to file an Investigational New Drug (IND) application for a safety and efficacy clinical trial. NovelMed's lead drug candidate is a highly promising, orally viable small molecule, which has already received an FDA approval in the US for other clinical indications. NovelMed has filed a patent application on this novel molecule for the treatment of arthritis. If successful, it could become a multi-billion dollar drug. Public Health Relevance: Annually billions of dollars is spent for arthritic patients. Current treatments are expensive and can only halt the progression of the disease. No treatment currently exists that is inexpensive and provides long-term benefit to RA patients. NovelMed has discovered an inexpensive treatment for arthritis patients and once approved by the FDA for arthritis, it would be available to the large population, which is anxiously waiting for an affordable treatment.