Shanghai, November 22, 2007: Hutchison MediPharma today announces that it 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, randomized, double-blind, and placebo-controlled clinical study of 210 patients with active mild-to-moderate UC. Patients will be enrolled and randomized 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. 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 centers worldwide including sites in North America and Europe.
Separately, HMPL-004, the leading candidate of Hutchison MediPharma’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.
Dr. Samantha Du, Managing Director of 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”.