Hutchison China Meditech Ltd. announced that it's wholly-owned drug R&D subsidiary, Hutchison MediPharma Limited has obtained clearance for its new Investigative New Drug (IND) application from the US Food and Drug Administration for its drug candidate, HMPL-004.
The IND will allow Hutchison MediPharma to commence a planned global phase IIb trial with HMPL-004 in patients with mild-to-moderate Ulcerative Colitis (UC), a form of inflammatory bowel disease. This clinical trial has been designed to assess the drug candidate's efficacy and safety profile in a broad patient population. Data from this study will be used to guide the design of the planned phase III global registration trials with HMPL-004.
In July 2007, Hutchison MediPharma announced a positive phase II proof-of-concept study with HMPL-004 in mild-to-moderate UC patients, which was conducted in China. The global phase IIb trial is a multi-centre, randomised, double-blind, and placebo-controlled clinical study of 210 patients with active mild-to-moderate UC. Patients will be enrolled and randomised into one of the HMPL-004 treatment arms that will receive either 1,200mg or 1,800mg of the active drug per day, or placebo. The primary endpoint of the trial will assess the efficacy of HMPL-004 compared with placebo after eight weeks treatment, said the company.
Secondary endpoints of the trial involve clinical remission, mucosal healing, and the dose response trend of the two treatment arms. Safety evaluations will be made throughout the trial period. The global phase IIb trial in UC will be conducted in approximately 50 clinical study centres worldwide including sites in North America and Europe. Separately, HMPL-004, the leading candidate of Chi-Med's drug pipeline for treating inflammatory bowl disease, is in phase II clinical trial in the US for Crohn's Disease. The trial is actively recruiting patients and Chi-Med anticipates reporting results by late next year
Dr. Samantha Du, chief scientific officer, Chi-Med and managing director, Hutchison MediPharma, said: "We are pleased to initiate a global multi-centre phase IIb trial of HMPL-004 for Ulcerative Colitis disease. Based on the promising results generated from the phase II proof-of-concept study in China and the candidate's novel mechanism of action, we believe that HMPL-004 has significant potential to provide an alternative and effective oral treatment to patients worldwide who suffer from Ulcerative Colitis, a chronic, painful and frequently recurring disease. This global trial reflects our strong belief in HMPL-004 as a viable drug candidate for the world market".
Chi-Med is the holding company of a pharmaceutical and healthcare group based primarily in China. Chi-Med focuses on research, development, manufacture and sale of pharmaceuticals, health supplements and other consumer health and personal care products derived from traditional chinese medicine and botanical ingredients.
Hutchison MediPharma is Chi-Med's wholly-owned drug R&D subsidiary and has at its disposal a team of around 140 scientists and staff focusing on discovery and development of botanical drugs, semi-synthetic natural product drugs, and synthetic single chemical entity drugs. Hutchison MediPharma currently has two candidates in clinical development in both the US and China. HMPL-002, a radiosensitiser for head and neck cancer and non-small cell lung cancer, is in phase I/II in the US and in proof-of-concept in China. HMPL-004, an inhibitor to a group of inflammatory cytokines, has completed the phase II proof-of-concept study in Ulcerative Colitis and is in phase II studies in Crohn's Disease in the US.
Hutchison MediPharma also has a pipeline of single new chemical entity discovery projects in auto-immune/ inflammatory diseases and oncology therapeutic areas. Chi-Med is majority owned by Hutchison Whampoa Limited, an international corporation listed on the Main Board of The Stock Exchange of Hong Kong Limited.
HMPL-004 is an orally active, proprietary botanical product that acts on multiple targets in the pathogenesis of inflammation. It is a compound extracted from a Chinese herb that has extensive history of use in China and South East Asia against respiratory infections and inflammation. Chi-Med's extensive preclinical work with HMPL-004 has shown that HMPL-004 acts on multiple cellular targets in the inflammatory signal transduction pathways resulting in suppressed inflammation cytokine expression including TNF-alpha, IL-1 beta and IL-6. HMPL-004 was demonstrated to inhibit TNF-alpha and IL-1 beta production in cell-based assays and is also able to inhibit NF-kB activation. The novel mechanism of action of HMPL-004, compared to current conventional therapies, including Mesalazine, allows it to access a unique patient population. HMPL-004 is currently also in phase II trial in the US for the treatment of Crohn's Disease and has completed a phase II proof-of-concept trial in mild-to-moderate Ulcerative Colitis in China.