LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.
ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).
Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.
Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 103/µL.
As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse rate was 0.16. Treatment significantly reduced the number of gadolinium-enhancing lesions from baseline (mean 1.5) to one year (0.3) among de novo patients.
This study was sponsored by Alkermes and Biogen.
—Glenn S. Williams