Alkermes, PLC, said on Monday that it has produced positive results from a phase one, randomized, double-blind clinical study of ALKS 8700, an oral monomethyl fumarate (MMF) molecule in development as a multiple sclerosis (MS) treatment.
In comparison to the currently marketed dimethyl fumarate, TECFIDERA, ALKS 8700 is designed to quickly and proficiently convert MMF in the body. Alkermes’ study evaluated multiple oral versions of ALKS 8700, compared with a placebo and active control groups in 104 volunteers.
The study's results suggest that ALKS 8700 was mostly well-tolerated and delivered MMF exposures that were comparable to TECFIDERA, Alkermes said. The patients given ALKS 8700 had less gastrointestinal compared to those who took TECFIDERA.
“This highly informative clinical study provided clear data regarding dose selection and supports our decision to advance ALKS 8700 twice daily into pivotal development later this year,” Alkermes Chief Medical Officer Elliot Ehrich said.
“In addition, it provided new insights into approaches for once-daily dosing options, which we will continue to pursue.”
MS is a disease of the central nervous system that disturbs the movement of information to and from the brain. Approximately 2.5 million people worldwide and 400,000 people in the U.S. have MS, most of whom are diagnosed between the ages of 15 and 50.
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases.