Ono's oral MS drug eliminates brain lesions in promising PhII study

An oral MS drug was credited with eliminating a large percentage of the brain lesions characteristic of the disease, encouraging the developers at Japan's Ono Pharmaceutical as they lay the foundation for a late-stage program.

The star of the Phase II show was ONO-4641, a tablet on which Ono partnered with Merck KGaA after the German pharma company scuttled its troubled cladribine program. Once a leader in the race to develop the first oral MS drug, Merck KGaA was forced to regroup after the cladribine failure. But with Novartis' ($NVS) Gilenya now under a cloud as regulators in Europe and the U.S. review patient deaths and reevaluate the risk/benefit profile of the drug, rivals in the MS market see improved opportunities for new therapies.

Investigators recruited 407 patients for the study, providing three different doses of ONO-4641 on a daily basis for 26 weeks. Brain scans were performed once every four weeks. And at the end of the study, the investigators found that a mid-range dose eliminated 92% of the brain lesions compared with a placebo. The trial supervisors concluded that there were cardiovascular issues raised among the patients--including changes in blood pressure--as well as liver enzyme elevation.

"In light of recent issues in the oral MS drug market, this is welcome news," said study author Dr. Timothy Vollmer of the University of Colorado in Denver. The results will be presented at the American Academy of Neurology meeting later this month.

Ono faces some stiff competition among MS drug developers. Biogen Idec ($BIIB) has been garnering promising results for its BG-12--now up for review--while Teva Pharmaceutical's ($TEVA) laquinimod pill is in late-stage studies.

- here's the press release