Date: 15-Sep-2020

Novartis Phase IIIb EXCHANGE & EXPAND Trials Show Mayzent To Be Safe Treatment Option In Patients With SPMS

Novartis announced that Mayzent (siponimod) analyses from the phase IIIb EXCHANGE and EXPAND trials showed Mayzent to be a safe treatment option that has benefits in cognitive performance and reduces the risk of disability progression in patients with progressing MS1-3. The data were presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting that is taking place September 11–13, 2020.

“One of the biggest goals for people living with MS is to be able to live their lives independently for as long as possible," said Norman Putzki, MD, global head of development, neuroscience. “The data presented today reinforces that through its beneficial effects on cognitive performance and delaying disability progression, and as an appropriate option for patients to safely switch to/from other treatments, Mayzent offers hope for people looking to achieve this important goal.”

The EXCHANGE study is a phase IIIb prospective, six-month open-label study evaluating the safety and tolerability of conversion to Mayzent from other disease-modifying therapies (DMTs) in patients with relapsing multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS). The interim analysis included 112 patients from 42 centers in the US who were eligible for the safety analysis.

The EXPAND study is a randomized, double-blind, placebo-controlled phase III study, comparing the efficacy and safety of Mayzent versus placebo in patients with SPMS with varying levels of disability. The post hoc EXPAND analysis found that in patients with active disease, an increased chance for clinically relevant improvement was observed and patients with active SPMS early and continuously treated with Mayzent experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment.