Chi-Med Announces Start of Patient Enrolment in a Global Phase IIb Ulcerative Colitis Clinical Trial of HMPL-004
Chi-Med announced its wholly-owned drug R&D subsidiary, Hutchison MediPharma Limited, has enrolled the first patient into its global Phase IIb trial programme assessing HMPL-004 in patients with mild-to-moderate ulcerative colitis ("UC"), a form of inflammatory bowel disease. This patient was screened and randomized per the study protocol at one of its clinical sites in the United States. The global clinical trial programme has been designed to further test the drug candidate's efficacy, assess its safety profile in a broader patient population and to evaluate different dose regimens in preparation for the Phase III trials with HMPL-004. The global Phase IIb UC trial will be conducted in approximately 50 clinical study centres worldwide including sites in North America and Europe. In July 2007, Chi-Med announced positive results from a Phase II proof-of-concept study conducted by Hutchison MediPharma with HMPL-004 in UC patients in China.
The global Phase IIb UC trial is a multi-center, randomized, double-blind, placebo-controlled clinical study which will recruit 210 patients with active mild-to-moderate UC. The patients will be randomized into one of the two HMPL-004 treatment arms, 1200mg/daily or 1800mg/daily, or the placebo arm. The primary endpoint of the trial is to assess the efficacy of HMPL-004 as compared with the placebo after eight weeks treatment. In the trial the efficacy of HMPL-004 will be assessed based on quantitative symptom reduction thresholds using the standard Mayo score as well as a rectal bleeding score derived from a colonoscopic examination. Secondary endpoints of the trial involve the clinical remission, mucosal healing, and the dose response trend of the two HMPL-004 treatment arms. Safety evaluations will be made throughout the trial period. It is anticipated that patient recruitment in this global clinical trial will be completed by third quarter 2009.
HMPL-004, the leading candidate of Chi-Med's drug pipeline for treating inflammatory bowel disease, is also being assessed as a potential treatment for Crohn's Disease ("CD"). The product candidate is in a Phase II clinical trial in the US which is actively recruiting patients and Chi-Med anticipates the completion of patient recruitment for this CD study by the end of 2008.
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