The drug candidate, NF-kappaB Decoy, is a selective and potent inhibitor of the transcription factor NF-kappaB, which is also implicated in inflammatory diseases such as eczema, asthma and IBD.
In preclinical studies, US biopharmaceutical company, Corgentech, demonstrated that the drug was effectively delivered to inflamed areas of the gut, significantly reduced inflammatory cell infiltrates and expression of proinflammatory genes, and reversed disease-associated weight loss and tissue damage in multiple chronic and acute preclinical models of IBD.
IBD is a disease of complex etiology and its cause has not been completely understood. Because IBD is chronic and typically has an onset before 30 years of age, patients generally require lifelong treatment. Thus, the range of pharmaceutical treatments available concentrates not on the cause but the symptoms. Therefore cylates and steroids currently form the basis of IBD therapeutics.
These data further corroborate preclinical data presented last month, which showed NF-kappaB Decoy's ability to decrease inflammation and swelling in preclinical models of eczema.
Corgentech is currently conducting a multi-centre, phase 1/2 clinical trial of NF-kappaB Decoy for eczema in the US involving approximately 75 patients, and a second trial of approximately 120 patients will begin enrolling patients. The study is expected to be conducted in Australia and Switzerland.
The company has not yet forecasted its plans relating to a clinical trial for IBD.
"NF-kappaB Decoy significantly reduces the inflammatory response associated with inflammatory bowel disease," said Leslie McEvoy, senior vice president of research at Corgentech.
"Based on these data, we believe that NF-kappaB Decoy could someday have therapeutic potential as a novel cross-functional drug in both Crohn's disease and ulcerative colitis," she added.
IBD represents a new therapeutic target for NF-kappaB Decoy that represents a significant unmet medical need. Current estimates place the worldwide IBD therapeutics market at $1.88 billion (€1.6 billion) in 2004. Growth is expected to continue at a compound annual growth rate of 8.9 per cent to reach approximately $2.88 billion (€2.4 billion) worldwide in 2009.
The market will grow more rapidly with the introduction of additional monoclonal antibodies along with Johnson & Johnson's currently available Remicade.
Mainstays of drug treatments for IBD include corticosteroids and immunosuppressants such as azathioprine (Imuran), methotrexate and cyclosporine. These medications dampen down the body's entire immune system in an effort to control the overactive immune response of the GI tract. While such treatments are effective in many with IBD, they may lead to increased risk of infections and other side effects.