Large, randomised study will investigate multiple oral formulations of novel MMF molecule
Alkermes has initiated a Phase I clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). The randomised, double-blind study will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared with both placebo and active control groups in approximately 125 healthy volunteers.
ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared with the currently marketed dimethyl fumarate, Tecfidera.
'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. 'ALKS 8700 leverages Alkermes’ expertise in prodrug chemistry and oral controlled-release formulations to offer potential differentiated tolerability and dosing for patients with MS.'
This phase 1 study will investigate the pharmacokinetics and pharmacodynamics of multiple formulations and doses of ALKS 8700, and is designed to determine those suitable to progress into advanced clinical testing. The initiation of the phase 1 study follows Alkermes’ 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.