Alkermes and Biogen have reported that diroximel fumarate demonstrated a statistically superior gastrointestinal (GI) tolerability profile compared to Tecfidera (dimethyl fumarate) in a Phase III EVOLVE-MS-2 study for relapsing-remitting multiple sclerosis (RRMS).
Diroximel fumarate is an investigational, oral fumarate candidate designed to convert to monomethyl fumarate in the body. It is intended for the treatment of RRMS.
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The multi-centre, double-blind, active-controlled EVOLVE-MS-2 trial compared the GI tolerability profiles of 462mg twice daily diroximel fumarate and 240mg twice daily dimethyl fumarate over five weeks in a total of 506 participants.
Its primary endpoint was the number of days subjects reported GI symptoms with an intensity score of ≥2 on the IGISIS rating scale.
Performed twice daily, the IGISIS assessed the intensity of certain GI symptoms, such as nausea, vomiting, upper and lower abdominal pain, and diarrhoea. A ten on the scale is said to represent extreme intensity.
During the trial, subjects on the investigational drug self-reported significantly fewer days of GI symptoms with IGISIS intensity scores of ≥2, compared to dimethyl fumarate.
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By GlobalDataThe most common adverse events in both treatment groups were flushing, diarrhoea, and nausea.
In the diroximel fumarate arm, 1.6% of all patients with AEs discontinued the study, versus 6% treated with dimethyl fumarate.
Of these discontinuations, 0.8% in the study drug group and 4.8% in the dimethyl fumarate group have been attributed to GI adverse events.
Alkermes medicines development and medical affairs chief medical officer and senior vice-president Craig Hopkinson said: “These results reinforce the safety and tolerability profile diroximel fumarate has consistently demonstrated across the EVOLVE-MS development programme, underscoring the potential importance of diroximel fumarate for the treatment of people living with relapsing-remitting MS.”
The EVOLVE-MS-2 study forms part of the EVOLVE-MS clinical programme, which is being conducted by Alkermes and Biogen under a global development and commercialisation deal.
