Chi-Med plans global Phase IIb trials of colitis drug candidiate

Hutchison MediPharma 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, a wholly-owned drug R&D subsidiary of Chi-Med, 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.

conducted in approximately 50 clinical study centres worldwide including sites in North America and Europe.

HMPL-004, the leading candidate of Chi-Med's drug pipeline for treating inflammatory bowl disease, is also 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 for Chi-Med and managing director of Hutchison MediPharma, said: "We are pleased to initiate a global multi-centre Phase IIb trial of HMPL-004 for UC 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 UC, 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".