RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera
Alkermes is funding a Phase 3 clinical trial evaluating the effects of its ALKS 8700 therapy on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients, compared to Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society.
ALKS 8700, an orally administrated form of monomethyl fumarate, is still under clinical development. Although similar to Tecfidera, ALKS 8700 is designed to have differentiated therapeutic features.
The EVOLVE-MS-2 trial (NCT03093324) assessing ALKS 8700 versus Tecfidera expects to enroll 420 RRMS patients between 18 and 65 years old. U.S. researchers will conduct the trial at 48 sites across 27 states and the District of Columbia.
This study takes part within the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical development program to assess ALKS 8700’s therapeutic and chemical characteristics, as well as its safety, compared to Tecfidera.
To be eligible for the study, participants must be in neurologically stable condition, with no evidence of relapse within 30 days before beginning treatment. Patients with progressive subtypes of the disease — such as primary progressive, secondary progressive or progressive relapsing MS — and those with a history of active or recurrent gastrointestinal symptoms, will not be included in the study. Nor will patients who have previously been treated with Biogen’s Tecfidera.
Participants of the EVOLVE-MS-2 will randomly receive, twice daily, oral capsules of ALKS 8700 or Tecfidera for five weeks. Those who complete the study may joine a two-year Phase 3 long-term safety study of ALKS 8700.
Researchers will evaluate primarily the incidence, frequency and duration of adverse gastrointestinal side effects (such as nausea, diarrhea and upper abdominal pain) caused by each drug. Overall safety, with assessment of treatment-related adverse side events, will also be determined.
The EVOLVE-MS program also includes a second ongoing Phase 3 study (NCT02634307) known as EVOLVE-MS-1. This clinical trial tests the safety of ALKS 8700 treatment in 935 RRMS patients, and is taking place at 107 research centers across the United States and Europe.
For more information on the EVOLVE-MS-2 trial, contact Emily Rebecca Moore, global project manager at INC Research, University of Texas Health Science Center, Houston. She can be reached at (512) 904-4325 or at [email protected]