HMPL-004: Phase III discontinued

Hutchison China MediTech said the double-blind, placebo-controlled, international Phase III NATRUL-3 trial of oral HMPL-004 was terminated on the recommendation of an independent DSMC after a planned interim analysis. Nutrition Science Partners Ltd. -- a 50/50 JV formed by Hutchison China and Nestle’s Nestle Health Science S.A. subsidiary -- said no safety signals or risks were identified and that the JV will “evaluate the potential opportunities of HMPL-004 in new indication areas and alternative regulatory pathways.” The trial was evaluating 600 and 800 mg HMPL-004 thrice daily for 8 weeks and planned to enroll about 420 patients with active UC who have an inadequate response to mesalamine. Patients who completed the NATRUL-3 were eligible to enroll in the Phase III NATRUL-4 trial to HMPL-004 as a 52-week maintenance therapy. ...