The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera (dimethyl fumarate). The 420 patients with relapsing-remitting MS (RRMS) will receive either 462 mg of ALKS 8700 twice a day or 240 mg of Tecfidera.
A prodrug is a compound the body converts into an active therapy. U.S. regulators have already approved Tecfidera, while ALKS 8700 is still in the treatment-candidate stage.
“ALKS 8700, a MMF prodrug with distinct physical-chemical properties, is designed to provide therapeutic concentrations of MMF in the body and offer differentiated features as compared to the market leader, dimethyl fumarate, TECFIDERA, which is associated with gastrointestinal side effects. These adverse events can lead to treatment interruption or discontinuation for patients with MS,” Elliot Ehrich, MD, Alkermes’ chief medical officer, said in a press release.
“We believe ALKS 8700 may represent a valuable new option for patients suffering from MS who want the efficacy of fumarate therapy with more favorable gastrointestinal tolerability,” Ehrich added.
The study, which will compare the treatments for five weeks, will start with a one-week titration, or dose-adjustment, period. Safety, the trial’s primary objective, will be demonstrated by the number of adverse events that occur. The events may include nausea, vomiting, upper and lower abdominal pain, and diarrhea.
Adverse events will be assessed with the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and the Global Gastrointestinal Symptom and Impact Scale (GGISIS). The intensity, frequency and duration of symptoms, as well as their effect on daily activities, will also be evaluated.
The Phase 3 trial is part of EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis), the ALKS 8700 trial development program.
“This elective study for ALKS 8700 demonstrates Alkermes’ unique approach to fully characterize the potential value of new medicines, reflecting our commitment to integrating inputs from patients, physicians and payers into our development programs in response to an increasingly complex healthcare system,” said Richard Pops, chief executive officer of Alkermes. “The data from this study will help determine ALKS 8700’s potential advantages for patients and its future positioning in the fumarate market, which represents a $3 billion opportunity in the U.S.”
Alkermes will submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in 2018 that covers ALKS 8700 as an RRMS treatment.
The company hopes ALKS 8700 offers qualities that Tecfidera lacks. One of Alkermes’ goals is for the body to convert the drug to MMF quickly and efficiently.
Alkermes completed a Phase 1 clinical trial in 2015 demonstrating that ALKS 8700 met the standards for being a bioequivalent therapy to Tecfidera.
For more information about the trial, including how to participate, please visit this link.