DAV0601 is being developed as an orally administered drug for the treatment of Inflammatory Bowel Diseases (IBD) including Ulcerative Colitis and Crohn’s disease. It is a "first-in-class NCE" with a novel mechanism of action with a potential to open new therapy segment in mild to moderate IBD with efficacy and safety superior to ASA analogues.

About IBD

IBD is characterised by abdominal cramps ranging from mild to severe, pain and bleeding of variable intensity and frequency during bowel motion, being responsible for substantial suffering and a highly compromised quality of life.

Current treatment management is largely symptomatic by oral administration of agents such as mesalazine and prednisone, both developed for diseases other than IBD and targeting only general inflammatory processess. Biological agents, administered intravenously, have been approved but their use is restricted to severe forms of Crohn's disease. Mild to moderate Crohn's disease and ulcerative colitis - making close to 90% of diagnosed patients - are symptomatically treated with ant-inflammatory agents and corticosteroids. The market is ripe for a target specific therapy.

In contrast to present therapies for mild to moderate IBD, DAV0601 is unique in its mode of action as it selectively blocks a target (neutral sphingomyelinase - nSMase) which mediates a specific event trigger that sustains IBD. The specific inhibition of nSMase also has potential application in other auto-immune inflammatory diseases such as multiple sclerosis and rheumatoid arthritis.

Development Status

nSMase inhibition has been demonstrated in human macrophages, murine monocytes and human T cells. Other mechanisms - such as CD95 induced apoptosis and cytokine secretion - have also been studied.

DAV0601 has shown efficacy in two different murine models for IBD when administered orally. Early toxicology in mice (upto 28 days dosing) show a clean profile for the drug. Structural chemistry, including isomerism details, is available. Currently, characterisation of the compound is in progress and GLP toxicology studies are expected to start in first quarter of 2009.

DAV0601 is planned to be developed as a modified release oral tablet.

Intellectual Property Position

Original EU (Austria, belgium, Switzerland, Germany, Spain, France, UK), Australia, New Zealand and US-substance patents have been granted, and new patent applications relating to the salts were granted in the US, Russia and Belarus and have been applied for in the EU, China, India and Japan.  Avicenna has acquired the worldwide development and licensing rights to DAV0601.
 
 
Contact for further product information