Shanghai: Wednesday, 24 April 2013: Nutrition Science Partners, a 50/50 joint venture between Hutchison Medi Pharma (“HMP”) 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 program 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 randomized double-blind, multi-center, placebo-controlled Phase III studies of HMPL-004.
|NATRUL-3:||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.|
|NATRUL-4:||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.|
|NATRUL-5:||This study is a second UC induction study to fulfill regulatory requirements.|
A separate Crohn’s disease program 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, HMP 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 personalized 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.”
About Inflammatory Bowel Disease
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.
HMPL-004 is a novel, oral therapy for IBD derived from a botanical extract. HMPL-004 was researched and developed by 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 characterized. 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 randomized Phase II trials completed by HMP in North America and Europe. In total the HMPL-004 Phase III clinical studies will enroll over 2,500 patients suffering from ulcerative colitis or Crohn’s disease, primarily in the US and Europe. The UC trial will be named NATRUL, standing for Natural Andrographis-based Treatment for the Remission of Ulcerative Colitis and the Crohn’s disease trial will be named upon commencement.
The cost of the HMPL-004 Phase III program and all gastrointestinal disease research and development activities will be funded primarily by Nestlé Health Science through the initial capital investment in NSP and further milestone payments to NSP linked to the success of clinical and commercial activities.
About Nestlé Health Science
Nestlé Health Science, a wholly-owned subsidiary of Nestlé, intends to spearhead the development of science-based personalized 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. For more information, please visit www.nestlehealthscience.com.
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.