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Chi-Med Announces Positive Phase II Proof-of-Concept Data for HMPL-004 in Ulcerative Colitis

05 Jul 2007 - Chi-Med, the Hutchison Whampoa backed pharmaceutical and healthcare Group, announced positive results for its Phase II proof-of-concept study for HMPL-004 in mild-to-moderate Ulcerative Colitis, a form of inflammatory bowel disease. The trial met its objective in that HMPL-004 was well tolerated and showed an equivalent drop in clinical symptom score to the comparator drug, Mesalazine, the current first-line standard of care in mild-to-moderate Ulcerative Colitis.
 
The Phase II proof-of-concept study, conducted by Chi-Med's wholly-owned drug R&D subsidiary, Hutchison MediPharma Limited, was a multi-center, randomized, double-blind, comparator study of 120 patients with mild-to-moderate Ulcerative Colitis conducted in China. The study evaluated HMPL-004 at 400mg taken three times a day, orally, compared to Mesalazine, the current first-line standard of care. The four trial endpoints were patients: clinical symptom score; overall clinical evaluation; colonoscopic score; and safety evaluation. After treatment for eight weeks, the percentage of patient> '> s clinical symptom score reduction for HMPL-004 was 56% versus 59% for Mesalazine in the Intent-To-Treat population. The overall remission rate (combination of complete and partial remissions) for HMPL-004 was 57% by clinical score compared to 53% for Mesalazine in the Intent-To-Treat population and 47% for HMPL-004 versus 42% for Mesalazine by colonoscopy in the Intent-To-Treat population. HMPL-004 was well tolerated in the study and the adverse event rate was half that of the Mesalazine group
 
HMPL-004 is an orally active, proprietary botanical product that acts on multiple targets in the pathogenesis of inflammation. It is a compound extracted from a Chinese herb that has extensive history of use in China and South East Asia against respiratory infections and inflammation. This documentation enabled Chi-Med to accelerate the clinical process for HMPL-004 by by-passing Phase I trials, based on the FDA's 2004 guidance on botanical drug products. HMPL-004 is currently also in Phase II trial in the US for the treatment of Crohn's Disease.