Experimental Medications: Other Therapeutic Strategies
In the Phase II DreaMS trial, 407 RRMS patients were randomized to placebo or one of three different doses of ONO-4641 (0.05 mg, 0.10 mg, or 0.15 mg once daily for 26 weeks).
All three treatment groups showed a substantial decrease in MRI disease activity as measured both by gadolinium-enhancing lesion numbers and new or enlarging T2 lesions. Compared to placebo, lesion counts were reduced by 82 percent in the 0.05 mg/day group; 92 percent in the 0.10 mg/day group, and 77 percent in the 0.15 mg/day group. The study was not designed to evaluate relapse rates or disability progression, but there was a statistically significant decrease in relapse rate (with the 0.10-mg dose). Adverse events were similar to those seen with Gilenya, including bradycardia and lymphopenia (a reduction in circulating lymphocytes) in some patients. These were dose-related and did not result in drug discontinuation.
As of early 2015, the companies developing ONO-4641 have decided not to continue investigations of this drug. It remains to be seen if this agent will proceed to a Phase III trial.