EMD Serono will present new data from programs assessing the efficacy and safety of Mavenclad (cladribine) and Rebif (interferon beta-1a), as well as investigative evobrutinib in treating relapsing forms of multiple sclerosis (MS) at the MSVirtual2020 meeting.
Findings are part of 54 abstracts being presented by EMD Serono, known as Merck KGaA outside North America, at the Sept. 11–13 meeting.
They include real-world data on Mavenclad, a review of Rebif’s use by pregnant patients and its safety in people with viral respiratory infections, and preclinical and early clinical trial efficacy results on evobrutinib.
“The broad range of research revealed through these data demonstrate our strategic approach to advancing the MS treatment landscape through new medicines and patient-focused research initiatives,” Luciano Rossetti, global head of Research & Development at EMD Serono, said in a press release.
Regarding Mavenclad, the company’s oral, short-course therapy for those with active and relapsing forms of MS, new data comes from the Phase 3 CLARITY trial (NCT00213135) and its extension study (NCT00641537) on the therapy’s long-term efficacy at reducing the incidence of cumulative MS relapses over five years.
Findings from a post-hoc analysis of CLARITY investigating the five-year effects of Mavenclad on patients’ disability — assessed by the Expanded Disability Status Scale (EDSS) — will also be presented.
The company will also present new data from two Phase 4 trials of Mavenclad — MAGNIFY (NCT03364036) and CLARIFY (NCT03369665) — including the clinical outcomes of MS patients infected with COVID-19 while taking the medication during these trials.
Long-term efficacy and real-world data from another Phase 4 Mavenclad trial, called CLASSIC MS (NCT03961204), will be presented as part of the late-breaker sessions taking place on Sept. 25–26.
Updated post-approval safety data covering both Mavenclad and Rebif in treating MS, including a look at the risk of respiratory infections of concern during the ongoing pandemic.
“Much of our data provide insights on how Mavenclad and Rebif affect the risk of respiratory viral infections and COVID-19 outcomes in MS patients. These insights will help support clinicians as they make treatment decisions for their patients living with MS,” Rossetti said.
New data will also come from an open-label extension of a Phase 2 trial (NCT02975349) assessing the long-term efficacy of its investigational, oral BTK inhibitor, called evobrutinib, in patients with relapsing forms of MS.
EMD Serono will also present findings from a preclinical study of evobrutinib’s potential in lowering inflammation in the central nervous system (CNS; composed by the brain and spinal cord), which is thought to be one of the key drivers of MS.
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