Nutrition Science Partners announces initiation and treatment of the first Ulcerative Colitis patient in the global NATRUL Phase III trial for the novel botanical oral drug HMPL-004
London: Wednesday, 24 April 2013: Nutrition Science Partners, a 50/50 joint venture between Chi-Med and Nestlé Health Science, today announces that the first patient has been enrolled and has begun treatment in the first global Phase III study of HMPL-004, NATRUL-3, in patients with mild-to-moderate ulcerative colitis (“UC”).
HMPL-004 is a proprietary, novel, botanical oral drug in late stage development for the treatment of inflammatory bowel disease (“IBD”). It has undergone multiple clinical trials in North America, Europe and Asia, which showed efficacy in the induction of clinical response, remission, and mucosal healing; as well as a clean safety profile.
The Phase III registration trial programme to be named NATRUL is designed to evaluate the efficacy and safety of HMPL-004 in patients with mild-to-moderate UC. It consists of three separate randomised double-blind, multi-centre, placebo-controlled Phase III studies of HMPL-004.
||The primary endpoint of this study is to evaluate 8-week treatments of 1,800 mg/day and 2,400 mg/day dosages of HMPL-004 compared with placebo in patients with active UC who have an inadequate response to their current treatment with Mesalamine. Secondary endpoints of this study include clinical response and mucosal healing. The NATRUL-3 study is expected to take approximately 24 months to complete.
||This study is designed to evaluate HMPL-004 as a 52-week maintenance therapy. Subjects who have completed NATRUL-3 will be eligible to enter NATRUL-4 directly.
||This study is a second UC induction study to fulfil regulatory requirements.
A separate Crohn’s disease programme will be triggered by satisfactory NATRUL-3 clinical data analysis. All HMPL-004 studies beyond NATRUL-3 will be announced separately upon treatment of their first patient.
The current standard of care for IBD starts with 5-aminosalicyclic acids (5-ASAs) which can induce and maintain clinical response and remission in an average of approximately 50% of IBD patients. For the 5-ASA non-responding patients with moderate-to-severe active diseases, various forms of corticosteroids and immunosuppressant drugs and anti-TNF agents such as biologics are prescribed. These agents, though effective, are associated with many side effects, sometimes serious, and are not often suitable for prolonged usage. There remain clear unmet medical needs for novel agents which can induce and maintain remission among 5-ASA non-responding or intolerant patients, and the need for safer agents without the side effects of corticosteroids and immune suppressors.
Dr. William Sandborn, Professor of Clinical Medicine at the University of California San Diego and Director of the IBD Center and Chief of the Division of Gastroenterology for the UC San Diego Health System, said: “At the moment there are limited alternatives available for UC patients with mild to moderate disease who are seeking a safe and effective therapy. As a natural oral product with promising efficacy and an excellent safety profile, I expect patients and physicians alike to be enthusiastic at its potential if this trial is successful.”
Christian Hogg, Chi-Med CEO said: “This is the first of what we expect to be many landmark events that will be achieved by our joint venture, Nutrition Science Partners, as it begins to invest in developing truly innovative and scientifically validated botanical based solutions for personalised healthcare. We are very pleased to start this global registration trial to help address IBD, a disease that is estimated to affect approximately 1.4 million in the US alone.”