Shanghai: Wednesday, July 17, 2013: Nutrition Science Partners, a 50/50 joint venture between HMP and Nestlé Health Science, today announces that the first patient has begun treatment in the second global Phase III study of HMPL-004, NATRUL-4, for 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.
NATRUL-4 is a global Phase III study designed to evaluate the efficacy and safety of HMPL-004 as maintenance therapy in adults with mild-to-moderate active UC. It consists of an open-label induction treatment phase and a randomised, double-blind, placebo controlled maintenance therapy phase. Patients entering the maintenance phase of this study are those who have achieved clinical remission or response during their participation in either a randomised double-blind, placebo controlled HMPL-004 induction study (NATRUL-3 or NATRUL-5), or the 8-week open-label HMPL-004 induction treatment phase of the study. Eligible patients (clinical remitters and responders) will be randomised to receive either HMPL-004 at 1,800 mg/day or placebo for 52 weeks as maintenance therapy.
The primary endpoint of this study is the proportion of patients who are in remission after 52 weeks of maintenance treatment, following either successful induction therapy to achieve remission, or successful induction therapy to achieve response.
Key secondary endpoints of this study include the proportion of patients that have maintained remission only after induction into remission; the proportion of patients that are in response after induction into either remission or response; and the proportion of patients that have maintained response following induction into response.
About Inflammatory Bowel Disease & the current standard of care
IBD involves chronic inflammation of all or part of the digestive tract and primarily includes UC and Crohn’s disease. IBD can be painful and debilitating, and sometimes leads to life-threatening complications.
UC is an inflammatory bowel disease that causes long-lasting inflammation in part of the digestive tract. Symptoms usually develop over time, rather than suddenly. UC usually affects only the innermost lining of the large intestine (colon) and rectum.
Crohn’s disease is an inflammatory bowel disease that causes inflammation anywhere along the lining of the digestive tract, and often spreads deep into affected tissues. This can lead to abdominal pain, severe diarrhoea and even malnutrition. The inflammation caused by Crohn’s disease can involve different areas of the digestive tract in different people.
The Crohn’s and Colitis Foundation of America estimates that approximately 1.4 million Americans suffer from IBD.
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.
About HMPL-004 & NATRUL
HMPL-004 is a novel, oral therapy for IBD derived from a botanical extract. HMPL-004 was researched and developed by Hutchison MediPharma (“HMP”). The drug acts on multiple targets in the pathogenesis of inflammation. It is a product extracted from a 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 HMP.
The clinical efficacy and safety of HMPL-004 in the treatment of IBD has already been demonstrated in over 400 patients, including randomised Phase II trials completed by HMP in North America and Europe. In total the HMPL-004 Phase III clinical studies will enrol over 2,500 patients suffering from ulcerative colitis or Crohn’s disease, primarily in the US and Europe.
NATRUL is the Phase III registration trial programme 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 first study, NATRUL-3, enrolled and treated its first patient in April 2013. Its primary endpoint is to evaluate treatments of HMPL-004 compared with placebo in patients with active UC who have an inadequate response to their current treatment with Mesalamine.
NATRUL-4 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. NATRUL-5 is a second UC induction study to fulfil regulatory requirements.
The cost of the HMPL-004 Phase III programme and all gastrointestinal disease research and development activities will be funded primarily by Nestlé Health Science through the initial capital investment in Nutrition Science Partners and further milestone payments to Nutrition Science Partners linked to the success of clinical and commercial activities.
About Nestlé Health Science SA
Nestlé Health Science, a wholly-owned subsidiary of Nestlé, intends to spearhead the development of science-based personalised nutritional solutions. Building on its core HealthCare Nutrition business, the company has ambitions to address chronic conditions in the area of Gastrointestinal Health, Metabolic Health and Brain Health. Nestlé Health Science offers nutritional solutions for people with specific dietary needs related to illnesses, disease states or the special challenges of different life stages. Nestlé Health Science employs around 3,000 people worldwide and has its headquarters in Lutry, Switzerland.
About Nutrition Science Partners
Nestlé Health Science and HMP have formed Nutrition Science Partners, a 50/50 joint venture. The purpose of Nutrition Science Partners is to research, develop, manufacture and market worldwide novel medicines and nutritional products derived from botanical plant origins. Nutrition Science Partners will focus on gastrointestinal indications, and may in the future expand into the metabolic disease and brain health areas.
HMP is a novel drug R&D company focusing on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.