Experimental Medications: Administered Orally
Company: Biogen and Alkermes plc.
- Oral medication; 462 mg taken twice daily
- Being studied in RRMS
ALKS 8700 is a “prodrug,” which is a biologically inactive compound that can be metabolized in the body to produce a drug. This medication is designed to convert to monomethyl fumarate in the body, and to offer features differentiated from Tecfidera (dimethyl fumarate) – so that it would work in much of the same manner as Tecfidera, but with a lower rate of gastrointestinal side effects. In November 2017, Biogen – the company that markets Tecfidera – announced that it had entered into an agreement with Alkermes, the Ireland-based developer of ALKS 8700, to collaborate on the further development and commercialization of this medication.35
ALKS 8700 is in Phase III development for RRMS. Research into ALKS 8700 includes a study to demonstrate that it is bioequivalent to Tecfidera and a two-year safety study known as EVOLVE-MS-1. Initial safety data from EVOLVE-MS-1 were presented at the ECTRIMS-ACTRIMS Meeting in 2017. Data from the first month of the study showed that from among 580 individuals receiving ALKS 8700, no serious gastrointestinal adverse events occurred. The most common adverse events during the first month of treatment were flushing, pruritus (itching), and diarrhea.35
EVOLVE-MS-1 will ultimately follow participants for up to 96 weeks, and will assess clinical relapses, laboratory results, and MRI findings, as well as adverse events and other measures.36
The ALKS 8700 research program also includes a head-to-head study (EVOLVE-MS-2) evaluating the gastrointestinal tolerability of ALKS 8700 compared to Tecfidera. Initial data from that trial are expected this year.35