The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ran from October 13 to 15, with companies globally presenting cutting-edge studies on MS.
The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTIRMS) ran from October 13 to 15, 2021, with companies globally presenting cutting-edge studies on multiple sclerosis (MS). Here’s a roundup of some of the top stories.
Sanofi’s Tolebrutinib Long-term Data
Sanofi presented favorable one-year tolerability data for its Phase IIb long-term extension study (LTS) of tolebrutinib in relapsing forms of MS (RMS). Tolebrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor. The data demonstrated that after 48 weeks of treatment, the drug decreased MS disease activity as measured by MRI.
“Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS,” said Erik Wallstrom, Therapeutic Area Head, Neurology Development at Sanofi. “For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients.”
BrainStorm’s NurOwn in Progressive MS
BrainStorm Cell Therapeutics presented findings from its Phase II trial of NurOwn in progressive multiple sclerosis. It was designed to evaluate intrathecal dosing of NurOwn (autologous MSC-NTF cells) in patients with progressive MS. The trial hit the primary endpoint of safety and tolerability, and reduced neuroinflammatory biomarkers as well as an increase in neuroprotective biomarkers in the cerebrospinal fluid (CSF). Consistent improvement in MS functional outcome measures were also observed.
“We were pleased that this study demonstrated safety, preliminary evidence of efficacy and relevant biomarker outcomes in patients with progressive multiple sclerosis, in an area of high unmet need,” said Jeffrey Cohen, Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and principal investigator for the trial. “These results should be confirmed in a randomized placebo-controlled trial.”
EMD Serono’s Evobrutinib in Relapsing MS
EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, provided data from a Phase II post-hoc analysis of its evobrutinib and its effects on brain lesions associated with chronic CNS inflammation in relapsing MS. Evobrutinib is a fully covalent Bruton’s tyrosine kinase inhibitor. The company indicates it was the first BTKi to demonstrate significant reductions in slowly expanding lesions (SEL), which are chronic, active, demyelinated MS lesions thought to be an early indicator of disease progression.
“New treatments are needed that target chronic neuroinflammation early in RMS to effectively prevent progression and accumulation of disability,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. “Evobrutinib’s first of its kind BTKi data on both SEL and NfL, which are thought to predict disease progression, further substantiate our belief in evobrutinib’s potential as a best-in-class treatment for people living with relapsing MS.”
Biogen Presented Data from its MS Portfolio
Biogen announced new data from its portfolio. This included results from the NOVA trial on efficacy of every six-week 300mg natalizumab IV administration, data from a comparative real-world study of Tysabri (natalizumab) compared to Ocrevus (ocrelizumab), and outcomes on GI tolerability, persistence and adherence for Vumerity (diroximel fumarate).
The Phase IIIb NOVA trial showed that every six-week dosing provided a high level of efficacy in controlling MS in patients who switched to the dosing regimen after at least one year of disease stability on the approved four-week IV dosing schedule.
The Tysabri versus Ocrevus study found that patients treated with Tysabri had a lower risk of relapse than patients receiving Ocrevus. Time to first relapse “significantly favored” Tysabri over Ocrevus.
And the EVOLVE-MS-2 study suggested consistent GI tolerability for Vumerity throughout dose titration. They concluded that this might simplify initiation of therapy and prevent delays in reaching maintenance dose.
“Our focus on improving the MS patient experience continues to shape research initiatives across Biogen’s MS portfolio, as demonstrated by presentations at this year’s ECTRIMS meeting,” said Maha Radhakrishnan, Chief Medical Officer of Biogen. “These new data build upon the existing body of real-world safety and efficacy evidence for extended interval dosing with natalizumab and highlight outcomes that are important to patients, including a reduced risk of relapse with Tysabri and new data on the ability for patients to achieve and maintain an improved gastrointestinal tolerability profile with Vumerity.”
Genentech’s Ocrevus OPERA I and II Trials
Genentech reported new long-term data from the Phase III OPERA I and II trials of Ocrevus for multiple sclerosis. The data demonstrated that Ocrevus led to a 35% decrease in risk of needing a walking aid in relapsing MS (RMS) patients after 7.5 years of use. Data also showed that changing from interferon beta-1a to Ocrevus at the start of the open-label extension (OLE) period was associated with a rapid and robust reduction in annualized relapse rate, which persisted through the 5.5-year OLE period.
