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LONDON, 2 July 2007: Chi-Med, the Hutchison Whampoa backed pharmaceutical and healthcare Group, today announces 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
(“Hutchison MediPharma”), 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 o
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