July 9, 2007
Hutchison MediPharma issued positive results from a phase II trial of HMPL-004 for the treatment of ulcerative colitis (UC). This randomized, double-blind, comparator study enrolled 120 subjects with mild to moderate UC in China. Subjects received HMPL-004 at 400 mg doses taken three times a day, orally, or Mesalazine, the current first-line standard of care for eight weeks. The four trial endpoints were clinical symptom score; overall clinical evaluation; colonoscopic score; and safety. In the Intent to Treat population, the clinical symptom score reduction for HMPL-004 was 56% versus 59% for Mesalazine. The overall remission rate (complete and partial remissions) for HMPL-004 was 57% compared to 53% for Mesalazine and 47% for HMPL-004 versus 42% for Mesalazine by colonoscopy. Treatment with HMPL-004 was well tolerated; with the adverse events rate half of that for the Mesalazine group. Hutchison is currently conducting additional phase II trials of HMPL-004 in the United States.
June 2, 2003
Sucampo Pharmaceuticals reported positive results from a phase III trial investigating SPI-0211, a chloride channel activator for the treatment of constipation. Results showed the treatment performed significantly better than placebo for all constipation variables tested. Data demonstrated a significant increase in spontaneous bowel movement frequency and significant improvements in straining and stool consistency. The drug was found safe and well tolerated. Study results were presented at the Digestive Disease Week 2003 Conference. The multi-center, randomized, placebo-controlled trial enrolled 242 subjects with occasional constipation and was designed to test the saftey and efficacy of SPI-0211 (24 mg) twice daily.