Irish biopharmaceutical company Alkermes has initiated a Phase I clinical trial of ALKS 8700, a novel monomethyl fumarate (MMF) to treat multiple sclerosis (MS).
The Phase I trial will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared with both placebo and active control groups in about 125 healthy volunteers.
The company said that ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and provide differentiated features compared to the currently marketed dimethyl fumarate, TECFIDERA.
Alkermes chief medical officer Elliot Ehrich said: "We expect the results of this study to be highly informative and determine the therapeutic utility and differentiating features of ALKS 8700.
"ALKS 8700 leverages Alkermes’ expertise in prodrug chemistry and oral controlled-release formulations to offer potential differentiated tolerability and dosing for patients with MS."
The randomised, double-blind trial is designed to investigate the pharmacokinetics and pharmacodynamics of multiple formulations and doses of ALKS 8700 as well as to determine those suitable to progress into advanced clinical testing.
The start of the Phase I trial follows the company’s filing of an investigational new drug (IND) application with the US Food and Drug Administration (FDA), and the issuance of a composition of matter patent for ALKS 8700 from the US Patent and Trademark Office (USPTO) in March 2014, which is expected to provide patent protection into 2033.
ALKS 8700 is a new and proprietary monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS).