A one-year analysis of the ongoing Phase 3 EVOLVE-MS-1 trial of ALKS 8700 as a therapy for relapsing remitting multiple sclerosis (RRMS) supports the experimental therapy’s effectiveness, with the treatment significantly reducing the number of MS lesions.
Interim results from the trial were presented Tuesday at the 2018 American Academy of Neurology (AAN) Annual Meeting in a presentation titled “MRI and Relapse Results for ALKS 8700 in Patients with Relapsing Remitting Multiple Sclerosis: 1-year Interim Results from the Phase 3 EVOLVE-MS-1 Study.” The event continues through April 27 in Los Angeles.
ALKS 8700, an oral investigational therapy developed by Alkermes, is a prodrug, meaning that once inside the body, it is metabolized into an active agent, in this case monomethyl fumarate (MMF). MMF is similar to the active agent in Biogen’s commercially available Tecfidera (dimethyl fumarate).
ALKS 8700 was designed to improve the active compound’s gastrointestinal tolerability.
Alkermes is currently assessing the safety and effectiveness of ALKS 8700 in two Phase 3 studies in patients with RRMS — the EVOLVE-MS-1 trial (NCT02634307) and the EVOLVE-MS-2 trial (NCT03093324). Both are enrolling MS patients. For trial information, click on the clinical trial numbers above.
The EVOLVE-MS-1 open-label study is ongoing at 107 U.S. and European research sites to evaluate the long-term safety of ALKS 8700 in about 930 RRMS patients. Participants receive 462 mg of ALKS 8700 twice daily.
After one year of treatment with ALKS 8700, the annualized relapse rate of 570 patients was 0.16. Of these patients, 152 were evaluated via magnetic resolution imaging (MRI).
MRI results showed that patients treated for a year with ALKS 8700 showed a significant reduction in the number of gadolinium-enhancing lesions, as well as T1-hypointense and T2 lesions, compared with when they first joined the trial.
In a previous analysis, researchers reported that ALKS 8700 was safe and well-tolerated, with patients showing a low incidence of gastrointestinal adverse events, and no reports of serious events.
The most common side effects associated with the treatment included flushing (redness of the skin, normally in the neck and cheeks), pruritus (itchy skin), and diarrhea.
The randomized EVOLVE-MS-2 trial, ongoing at 48 U.S. sites, will compare the safety and effectiveness of ALKS 8700 with Tecfidera in 420 RRMS patients.
“These preliminary findings suggest ALKS 8700 may be an effective oral treatment option for patients with RRMS,” the researchers wrote.