Clinical Trials Resource Center

New Medical Therapies™

Latest New Medical Therapy Results

Week of November 16, 2009

Hutchison Medipharma reported positive results from a phase IIb trial of HMPL-004 for the treatment of ulcerative colitis. This multi-center, randomized, double-blind, and placebo-controlled study enrolled 223 subjects with active mild-to-moderate UC. The subjects received either 1,200mg or 1,800mg of HMPL-004 per day or placebo for eight weeks. The primary efficacy endpoint was clinical response, defined as the percentage of subjects with a decrease in Mayo score from baseline ≥ 3 and ≥ 30% decrease in the Mayo score, along with either a decrease in rectal bleeding score 1 or absolute rectal bleeding score ≥ 1 at Week 8. For the Intent-To-Treat population, the total clinical response of the two treatment arms at Week 8 was 64% for HMPL-004 vs. 44% for placebo (p ≡ 0.006). For the higher dose 1800 mg/day arm, the clinical response at Week 8 was 73% for HMPL-004 vs. 44% for placebo (p < 0.001). Secondary endpoints included clinical remission, defined as the percentage of patients with a Mayo score ≤ 2 with no individual score > 1 at Week 8; and the mucosal healing rate. The clinical remission at Week 8 was 43% vs. 28% for HMPL-004 vs. placebo (p ≡ 0.03). The mucosal healing rate at Week 8 was 53% vs. 36% for HMPL-004 vs. placebo (p≡0.02). For the higher dose 1800 mg/day arm, the clinical remission at Week 8 was 45% for HMPL-004 vs. 28% for placebo (p ≡ 0.04); and the mucosal healing rate at Week 8 was 60% for HMPL-004 vs. 36% for placebo (p≡0.007). HMPL-004 demonstrated a good safety profile at both dose levels and there were no treatment-related serious adverse events in either of the HMPL-004 arms.