Shanghai: Monday, 13 July 2009: Hutchison MediPharma Limited (“Hutchison MediPharma”) announced encouraging results from the completed Phase II trial for HMPL-004, the innovative oral drug developed for treatment of patients with active mild to moderate Crohn’s Disease (CD), a form of Inflammatory Bowel Disease (IBD).
The Phase II CD trial was a multi-centre, double blind, randomized, and placebo-controlled study conducted in 101 CD patients in the United States (73 patients) and Ukraine (28 patients). The clinical study included 8 weeks treatment with HMPL-004 or a placebo and then 4 weeks of follow up. The primary endpoint of the trial was to assess the efficacy, the percentage of subjects with a clinical response -100 (minus 100), defined as a reduction in Crohn’s Disease Activity Index (CDAI) by at least 100 points from the baseline. Secondary endpoints include the clinical response -70 (minus 70), defined as CDAI reduction of at least 70 points, and the percentage of subjects attaining remission, defined as CDAI score of 150 or less, were also assessed.
While the full trial report is pending, the outcomes of the completed data analysis are encouraging and demonstrate a trend of efficacy for HMPL-004. For the Intent-To-Treat (ITT) patient population, the clinical response -100 at week 8 was 37% for HMPL-004 versus 22% for the placebo (p = 0.087). The clinical response -70 at week 8 was 49% for HMPL-004 versus 32% for the placebo (p = 0.061). The remission rate at week 8 was 29% for HMPL-004 versus 14% for the placebo (p = 0.069). Furthermore, HMPL-004 demonstrated a good safety profile. There were no treatment-related serious adverse events in the HMPL-004 arm.
Dr. Samantha Du, CEO of Hutchison MediPharma, commented: “We are very much encouraged by the Crohn’s Disease trial results. HMPL-004 is an innovative oral botanical substance, extracted from a herb that grows naturally in China, and with a unique mechanism of action. It represents a new approach for a disease with currently limited treatment options and offers the potential to address a significant unmet medical need. In this clinical study, HMPL-004 showed a trend of efficacy and was well tolerated by patients. We are conducting subgroup analysis and will be publishing the data in the coming months. Today’s results, and those we look forward to from our ongoing global Ulcerative Colitis trial, will provide us with a strong platform for further development of HMPL-004 and progress towards partnering for commercial deployment.”
Currently, HMPL-004 is undergoing a global Phase IIb trial for Ulcerative Colitis (UC) that involves 210 patients with mild-to-moderate UC conditions. The UC trial is near its patient recruitment target and is expected to complete and report results before the end of the year.
HMPL-004 is an orally active, proprietary botanic product that acts on multiple targets in the pathogenesis of inflammation. It is a compound extracted from a Chinese herb under controlled conditions and its composition is well characterised. The anti-inflammation activity of HMPL-004 was originally identified in a cell-based anti-inflammation screening assay at Hutchison MediPharma, and further confirmed in various experimental pharmacology models.
About Crohn’s Disease
CD is an idiopathic, immune-mediated disorder currently believed to result from a cascade of processes initiated by unidentified antigens. The global IBD market is expected to undergo 4.6% growth during the forecast period from $2.6 billion in 2007 to $4.1 billion in 2017 (Source: Datamonitor, September 2008). The disease is characterised by flare-ups of symptoms such as diarrhea, abdominal pain, rectal bleeding and loss of appetite, alternating with periods of remission. Systemic complications of chronic disease include weight loss, anemia and increased risk of bowel cancer.