SHANGHAI – A joint venture between a Chinese and a Swiss company has launched Phase III trials for a botanical drug to treat inflammatory bowel disease.
Nutrition Science Partners Ltd. (NSP), a 50/50 JV between Hutchison China Meditech Ltd. (Chi-Med) and Nestle Health Science SA, of Lutry, Switzerland, will run Phase III trials on HMPL-004.
Chi-Med is owned by UK-listed biotech Hutchison Medipharma Ltd., of Shanghai.
“This is the first of what we expect to be many landmark events that will be achieved by our joint venture,” said HMP CEO Christian Hogg.
Long considered a pioneering effort in oral botanicals, HMPL-004 is based on traditional Chinese medicine (TCM) but developed as a Western medicine product. Multiple clinical trials to date in Asia, Europe and North America have shown efficacy in important aspects of mild to moderate ulcerative colitis (UC) in more than 400 patients. The new trials are targeting both UC and Crohn’s disease indications.
More companies are combing through TCM products in search of new compounds that can be developed into Western medicines. The China Association of Traditional Chinese Medicine reported the TCM market should be worth $88 billion by 2017. TCM accounts for about 40 percent of the Chinese pharmaceutical market.
HMPL-004’s main active ingredient is extracted from the herb Andrographis paniculata, which is grown across southeast Asia and used in TCM.
Botanicals have been slow to catch on outside China. In 2004 the FDA put forward regulations for the approval of botanicals, but has only approved two products to date: Fulyzaq (crofelemer, Salix Pharmaceuticals Ltd.) in 2013 and Veregen (kunecatechins, MediGene AG), in 2006.
While botanicals are considered safer than synthetics, they are notoriously difficult to reduce to a simple replicable chemical compound necessary for the new drug approval process.
NSP was set up in April to research, develop, manufacture and market products derived from botanicals. Nestle is funding the Phase III trials for HMPL-004 through the initial capital investment in NSP and further milestone payments linked to clinical and commercial activities.
HMP declined to specify the location and size of NSP.
Through the JV, Nestle Health Science gains access to Chi-Med’s extensive library of more than 50,000 TCM extracts from more than 1,200 herbal compounds. Chi-Med is the parent company of HMP.
HMP started examining and cataloguing TCM products at the beginning of the decade.
HMPL-004 acts on multiple targets in the pathogenesis of inflammation. The drug is extracted from a single herb and formulated as a solid dosage. Its main advantages compared to other inflammatory cytokine inhibitors are low cost and ease of use; it is taken orally rather than through injection. In Phase II trials, HMPL-004 outperformed Pentasa (Ferring Pharmaceuticals SA, mesalazine), the current first-line product.
NSP now plans to move on to Phase III trials. Named NATRUL, the trials will include 2,500 patients in three separate randomized double-blind, multicenter, placebo-controlled studies.
NATRUL-3 started in April and will last more than two years.
NATRUL-4 was announced in July and will look at the efficacy of HMPL-004 as a maintenance therapy commonly for IBS and Crohn’s. It will last one year.
NSP hopes HMPL-004 will keep sufferers in remission with fewer side effects.
“At the moment, there are limited alternatives available for UC patients with mild to moderate disease who are seeking a safe and effective therapy,” said 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. “I expect patients and physicians alike to be enthusiastic at its potential if this trial is successful.”
HMP has a team of 200 scientists and staff and long-term strategic partnerships with multinationals like Astrazeneca plc, Johnson & Johnson Co., Eli Lilly and Co., Merck Serono SA and Nestle Health Science Limited. The deal with J&J is reportedly the largest in the Chinese pharma sector worth $100 million in up-front and milestone payments.