Shanghai: Wednesday, 29 July 2009: Hutchison MediPharma Limited (‘Hutchison MediPharma’), today announced the completion well ahead of schedule of patient enrolment into a Phase IIb trial of HMPL-004 patients with mild-to-moderate Ulcerative Colitis (‘UC’), a form of inflammatory bowel disease (IBD). Results from this trial are now expected to be available in the fourth quarter of this year.
Today’s announcement follows both the positive results for HMPL-004’s Phase II proof-of-concept study conducted in UC patients in China, announced in July 2007, and the recent encouraging results of HMPL-004’s Phase II trial in Crohn’s Disease in the US and Ukraine, announced on 13 July this year.
The global Phase IIb UC clinical trial is designed to further test the drug candidate’s efficacy and safety profiles in a broad patient population and different dose levels in preparation for the Phase III registration trials. The patient recruitment of the global UC trial involved some 50 clinical study centers worldwide including sites in North America and Europe.
The global phase IIb UC trial is a multi-center, randomized, double-blind and placebo-controlled clinical study of 210 patients with active mild-to-moderate UC. In the trial, the patients are enrolled and randomized into one of the HMPL-004 treatment arms, 1200mg/daily or 1800mg/daily, or the placebo arm. The primary trial objective is the efficacy of HMPL-004 in clinical response as compared with the placebo after 8 weeks treatment. The clinical response is defined by the quantitative symptom reduction thresholds using the standard Mayo score, along with the rectal bleeding score from the colonoscopic examination. Secondary end points of the trial involves the clinical remission, mucosal healing, and the dose response trend of the two treatment arms. Safety evaluations will be made throughout the trial period.
HMPL-004 is an orally administrated, proprietary botanical product that acts on multiple targets in the pathogenesis of inflammation. It is extracted from a Chinese herb that has an extensive history of use in China and South East Asia against respiratory infections and inflammation.
Hutchison MediPharma’s extensive preclinical work has shown that HMPL-004 acts on multiple cellular targets in the inflammatory signal transduction pathways resulting in suppressed inflammation cytokine expression including TNF-alpha, IL-1 beta and IL-6. HMPL-004 was demonstrated to inhibit TNF-alpha and IL-1 beta production in cell-based assays and is also able to inhibit NF-kB activation. The novel mechanism of action of HMPL-004, compared to current conventional therapies, including Mesalazine, allows it to access a unique IBD patient population.