Alkermes plc is looking to add one more treatment to the repertoire for multiple sclerosis drugs by initiating a Phase 1 clinical trial study of ALKS 8700. This novel molecule, developed by Alkermes, will be evaluated for safety, tolerability, and pharmacokinetics.
“We expect the results of this study to be highly informative and determine the therapeutic utility and differentiating features of ALKS 8700,” said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes, in a news report. “ALKS 8700 leverages Alkermes’ expertise in prodrug chemistry and oral controlled-release formulations to offer potential differentiated tolerability and dosing for patients with multiple sclerosis.”
Complete details of the trial are not yet available on clinicaltrials.gov, but several oral formulations of ALKS 8700 will be tested against placebo and active controls in approximately 125 healthy volunteers, as this is a Phase 1 trial. The pharmacokinetics and pharmacodynamics determined in this trial will determine the doses suitable for follow-up clinical tests that will evaluate multiple sclerosis patients.
Initiation of the Phase 1 trial follows Alkermes filing an Investigation New Drug application with the Food and Drug Administration. A patent filed in March 2014 is expected to provide Alkermes protection of ALKS 8700 until the year 2033.
ALKS 8700 is a novel monomethyl fumarate molecule. As a prodrug, it will be rapidly and efficiently converted into monomethyl fumarate once in the body and is expected to act different from TECFIDERA (dimethyl fumarate), which is currently on the market for relapse-remitting multiple sclerosis treatment. If successful in clinical trials, ALKS 8700 may be added to the portfolio of over 20 drugs produced by Alkermes indicated to treat conditions such as addiction, schizophrenia, and depression.