Ireland-based biopharmaceutical firm Alkermes has started a Phase III clinical trial of ALKS 8700 for the treatment of relapsing forms of multiple sclerosis (MS).
ALKS 8700 is an oral monomethyl fumarate (MMF) prodrug candidate designed to rapidly and efficiently convert to MMF in the body.
The multicentre, double-blind, active-controlled, five-week Phase III trial will evaluate the gastrointestinal (GI) tolerability of ALKS 8700 compared to TECFIDERA in around 420 patients with relapsing-remitting MS (RRMS).
Alkermes chief executive officer Richard Pops said: “This elective study for ALKS 8700 demonstrates Alkermes’ unique approach to fully characterise the potential value of new medicines, reflecting our commitment to integrating inputs from patients, physicians and payers into our development programmes in response to an increasingly complex healthcare system.
“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 $3bn opportunity in the US.”
The elective trial is part of the ongoing ALKS 8700 clinical development programme EVOLVE-MS.
During the trial, GI symptoms such as nausea, vomiting, upper and lower abdominal pain and diarrhea will be measured using the individual gastrointestinal symptom and impact scale (IGISIS) and the global gastrointestinal symptom and impact scale (GGISIS).
The intensity, frequency, duration and effect of the symptoms on the daily activities will be examined.
Alkermes intends to submit a new drug application (NDA) for ALKS 8700 for the treatment of RRMS to the US Food and Drug Administration (FDA) next year.