Shanghai: Friday, 30 October 2009: Hutchison MediPharma Limited (“Hutchison MediPharma”) today announces the initiation of the first-in-human Phase I clinical trial of its proprietary anti-inflammatory drug candidate, HMPL-011, in Australia. The first subjects were dosed on 28 October.
HMPL-011 is a new chemical entity with a novel mechanism of action. It is a novel cytokine modulator being developed as an oral therapy for auto-immune diseases. In pre-clinical studies, the drug candidate has shown efficacy in animal models of rheumatoid arthritis, multiple sclerosis, and other auto-immune diseases. It has demonstrated an acceptable safety margin in animal toxicological evaluations.
The study is a randomized, placebo-controlled, double-blinded, single ascending dose trial in healthy male volunteers. The primary objective of the trial is to evaluate the safety, tolerability, and pharmacokinetics of HMPL-011 after single dosing. The study is expected to report results in the first half of year 2010.
Dr. Samantha Du, CEO of Hutchison MediPharma, said: “The initiation of human clinical studies of HMPL-011 is another very important milestone for Hutchison MediPharma. HMPL-011 has the potential to bring the option of a new class of treatment for multiple types of auto-immune disease patients. We are excited about our discovery and development portfolio and their potential to bring new and significant therapeutic benefits to the patients worldwide.”
About Autoimmune Diseases
Autoimmune diseases, mainly rheumatoid arthritis (RA), inflammatory bowel disease (IBD), lupus, and psoriasis, are caused by the dysfunction of the immune system in which the body attacks its own organs, cells, and tissues. These disorders afflict millions of patients, an estimated 5-8% of the world population. Most autoimmune diseases disproportionately affect women, and they are among the 10 leading causes of death for women in every age group up to 64 years old. Recent growth in the market has been driven by new monoclonal antibodies, which have proved very effective. However, they have significant side effects and are very costly on a per treatment basis. There is strong unmet market need in developing a novel small molecule that is as effective, but with fewer side effects and lower costs.
HMPL-011 is a novel small molecule cytokine modulator that controls the production of pro-inflammatory cytokines. It has shown good efficacy in animal models of a variety of inflammatory disorders.