BioCentury
ARTICLE | Clinical News

Ono's S1P receptor agonist meets RRMS endpoint

April 18, 2012 1:08 AM UTC

Ono Pharmaceutical Co. Ltd. (Tokyo:4528; Osaka:4528) said once-daily 0.05, 0.1 and 0.15 mg doses of oral ONO-4641 all met the primary endpoint of reducing the number of gadolinium-enhancing lesions in four-week intervals for 26 weeks vs. placebo in the Phase II DreaMS trial to treat relapsing-remitting multiple sclerosis (RRMS). Specifically, patients receiving low-, mid- and high-dose ONO-4641 had 82%, 92% and 77% fewer gadolinium-enhancing lesions, respectively, relative to placebo (p<0.0001 for all). Ono said adverse events appeared to be generally dose related and included slower heartbeat, atrioventricular blocks upon treatment initiation and liver enzyme elevations. The double-blind, international trial enrolled 407 patients aged 18-55. Data will be presented at the American Academy of Neurology meeting in New Orleans, which begins April 21. ONO-4641 is a sphingosine 1-phosphate (S1P) receptor agonist. ...