RedHill and Quest Develop MAP Test for Crohn's Disease

(Tel Aviv, Israel) has signed a collaboration agreement with Quest Diagnostics Inc. (Madison, NJ, USA) to develop a diagnostic test for Mycobacterium avium subspecies paratuberculosis (MAP) in the blood of patients with Crohn's disease.

The agreement is part of RedHill's preparations for clinical trials of its drug RHB-104. RedHill is planning a Phase III clinical trial of RHB-104 in Europe and a Phase II/III clinical trial of the drug in the US, to be carried out in 2012. RedHill believes that it will have a greater chance of positive results in its clinical trials if it recruits only Crohn's disease patients with MAP bacteria.

RHB-104 is a proprietary antibiotic drug combination for MAP infection in Crohn’s disease. RHB-104 will be indicated for treatment of MAP infection in Crohn’s patients. MAP bacteria are suspected as being the underlying cause for Crohn’s disease symptoms.

There is currently no available treatment for MAP infection in Crohn’s disease, and no other effective cure for Crohn’s disease. Current standard of care includes 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulating drugs (e.g., Methotrexate) and antitumor necrosis factor α (TNF α) such as e.g., Remicade. However, standard care lacks a long lasting treatment with minor side effects. RHB-104 holds promise for providing long-term remission with reduced side effects allowing affected patients to lead normal lives.

In September 2011, RedHill acquired exclusive rights to a diagnostic test for MAP bacteria from the University of Central Florida Research Foundation Inc. (UCF; Orlando, FL, USA). MAP bacteria are a suspected trigger of Crohn's in 40%-50% of carriers. The scientists at RedHill believe that it will have a greater chance of positive results in its clinical trials if participants include only Crohn's patients with MAP bacteria.

Saleh Naser, a professor at UCF's College of Medicine, developed the technology for the test. Roughly, half of Crohn's sufferers have MAP in their system, and the test should be able to identify those who carry the bacteria.

Patrick Mclean, who is the RHB-104 product manager for RedHill, said in a UCF article that acquisition of the test represented a "key milestone" in the development of a Crohn's treatment.

Related Links:
RedHill Biopharma
Quest Diagnostics
University of Central Florida Research Foundation Inc.