Shanghai: Tuesday, March 9, 2010: Hutchison MediPharma today announces that the details of the company’s lead development program for Inflammatory Bowel Disease (IBD), HMPL-004, have been selected for a Distinguished Abstract Plenary oral presentation during the 2010 Digestive Disease Week (DDW) conference at the Ernst N. Morial Convention Center in New Orleans, LA, USA, on May 1 to May 5, 2010. The results from HMPL-004’s global Phase IIb clinical trial in patients with mild to moderate active Ulcerative Colitis (UC) will be presented by Dr. William J. Sandborn, Professor of Medicine at the Department of Gastroenterology & Hepatology of the Mayo Clinic, in a Distinguished Abstract Plenary session of the American Gastroenterological Association (AGA) Institute.
The top-line trial analysis first released on November 5, 2009 demonstrated that the trial clearly succeeded in meeting its primary efficacy endpoint of clinical response with a decrease in rectal bleeding. It also met its key secondary endpoints in relation to clinical remission and mucosal healing.
The details of the session and the abstract presentation are as follows:
Session Title: Immunology, Microbiology and Inflammatory Bowel Diseases (IMIBD) Distinguished Abstract Plenary
Date and Time: May 4, 2010 from 4:00 PM to 5:30 PM
Abstract Title: Double Blind Placebo Controlled Phase IIb Trial of HMPL-004 in Active Mild to Moderate Ulcerative Colitis
Presentation Time: 5:15 PM to 5:30 PM
The Phase IIb UC trial was a multi-centre, double-blind, randomized and placebo-controlled study conducted in 223 UC patients in the United States, Canada and Europe. The three-armed clinical trial included 8 weeks treatment of HMPL-004 at two dose levels, 1200 mg/day or 1800 mg/day, vs. placebo. Top-line data analysis demonstrated that all primary and key secondary endpoints were achieved. In addition, HMPL-004 demonstrated an excellent safety profile at both dose levels. There were no treatment-related serious adverse events in either of the HMPL-004 arms reported by the investigators.
“The IMIBD distinguished plenary session is very prestigious, indicating that this was one of the highest ranked IBD abstracts,” said Dr. Samantha Du, PhD, Chief Executive Officer of Hutchison MediPharma. “HMPL-004 is an innovative oral therapy with a unique mechanism of action. The good safety and efficacy results of its Phase IIb UC trial have clearly shown the potential of HMPL-004 as a new approach for the treatment of this chronic and debilitating disease.”
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the AGA Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 to May 5, 2010, at the Ernest N. Morial Convention Center in New Orleans, LA, USA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
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 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.
About Inflammatory Bowel Diseases (“IBD”)
Ulcerative Colitis (“UC”) and Crohn’s Disease (“CD”) are the two most common forms of IBD. The patient population with UC and CD in the United States is estimated to be between 250,000-500,000 and 400,000-600,000 respectively. The estimated annual new incidences of UC and CD in the US are 2-7 cases per 100,000 and 5-7 cases per 100,000, respectively. Between 2001 and 2005 it is estimated that the number of patients with UC in the United States increased by approximately 47,000, representing a CAGR of 4% and the number of patients with CD increased by approximately 58,000, a CAGR of 3%. Information in this paragraph was provided by Cambridge Consultants Limited in 2006.