Chi-Med Plans to Initiate Global Phase IIb Trials of its Lead Anti-Inflammatory Drug Candidate, HMPL-004, in Ulcerative Colitis
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. 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.
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