Not intended for UK and US based media
- Company to present 54 abstracts across its MS portfolio - MAVENCLAD() (cladribine tablets), Rebif() (interferon beta-1a) and investigational evobrutinib
- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD()
- New MAVENCLAD() and Rebif() safety data to be shared demonstrating no increased risk of respiratory viral infections
DARMSTADT, Germany, Sept. 3, 2020 /PRNewswire/ -- Merck, a leading science and technology company, today announced it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8(th) Joint ACTRIMS-ECTRIMS Meeting. Merck will present 54 abstracts at the meeting, taking place virtually from 11-13 September 2020, including new efficacy and real-world safety data on MAVENCLAD() (cladribine tablets) and new safety data for Rebif() (interferon beta-1a).
In addition, data will be presented demonstrating investigational evobrutinib is the first and only Bruton's Tyrosine Kinase inhibitor (BTKi) to demonstrate high and sustained efficacy through 108 weeks in clinical studies. Preclinical data will also be presented providing insights into evobrutinib`s potential impact on progression in MS.
"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," said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. "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."
Key MAVENCLAD() (cladribine tablets) data include:
-- Early onset of action: Efficacy results from the Phase IV MAGNIFY-MS study, demonstrating an early onset of action from end of month one through a reduction in mean combined unique active (CUA) lesion count in the first six months of MAVENCLAD() treatment for highly active relapsing multiple sclerosis (RMS) -- Sustained efficacy: - New data evaluating cumulative relapse incidence over five years in patients enrolled in the CLARITY and CLARITY Extension trials, showing the sustained efficacy of MAVENCLAD( - )Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD(), with eight to 14 years of follow up, will be available as part of the late-breaker sessions from 25 September 2020 -- Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with MAVENCLAD() had a greater prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS) -- COVID-19 patient cases: Results from the MAGNIFY and CLARIFY studies, demonstrating clinical outcomes in patients with COVID-19 infection during these Phase IV studies of MAVENCLAD() for the treatment of MS will be available as part of the late-breaker sessions from 25 September 2020 -- Updated post-approval safety data of MAVENCLAD() in the treatment of MS showing that respiratory viral infections were typically non-serious, and consistent with that from the clinical development program
Key Rebif() (interferon beta-1a) data include:
-- Post-approval results on the safety of Rebif() in the treatment of MS, showing no new safety signals, including no increased risk for respiratory viral infections
Key evobrutinib data include:
-- Results of the Phase II open-label extension (OLE) in patients treated with evobrutinib 75 mg BID (twice a day), showing the efficacy at Week 48 was maintained at 108 weeks (ARR, 0.11) and the maximum efficacy observed with BID dosing correlated with optimal BTK occupancy achieved with BID dosing -- Safety results from the >=60 week Phase II OLE showing no new safety signals identified, consistent with data seen in more than 1,200 patients who have received evobrutinib to date, across MS and other conditions -- Preclinical data demonstrating evobrutinib's potential to reduce CNS compartmentalized inflammation thought to drive the progression of disability seen in MS
Additional Merck activities at MSVirtual2020:
-- Live presentation "Exploring the role of real-world data in multiple sclerosis" chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry (12 September 2020, 14:30-15:30 EDT / 20:30-21:30 CEST; recording available after the event) -- Two product theatres on demand throughout the congress starting from 11 September 2020, 11:45 EDT / 17:45 CEST - "Multiple sclerosis patient management: update from the UK" by Dr. Wallace Brownlee, MS Specialist Neurologist, National Hospital for Neurology and Neurosurgery, and MS researcher at Queen Square MS Centre, University College London Institute of Neurology- "Real-world multiple sclerosis management: what can we learn from MSBase?" by Dr. Suzanne Hodgkinson, Associate Professor, University of New South Wales, and a senior consultant neurologist at Liverpool Hospital, New South Wales, Australia
Today, Merck has launched a newsroom for journalists interested in the company`s latest developments and news - merckneurology.com/newsroom - where, among other information, background information on Merck MS treatments, and video presentations from the below will be available:
-- Merck's commitment to MS: Andrew Paterson, Senior Vice President, Head of Global and US Multiple Sclerosis Franchise, Merck -- An overview of MAVENCLAD() MAGNIFY data: Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery & Neuroscience, University of Siena, Italy -- Evobrutinib clinical trial update: Robert Henderson, Vice President, Global Program Leadership, Neurology & Immunology, Merck
Following the conclusion of MSVirtual2020, Merck will be hosting "Mastering the Neuroscience of Unconscious Bias," the inaugural virtual event for Merck's I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is an initiative started by Merck`s Neurology & Immunology franchise, which aims to explore solutions together with healthcare providers to improve equity within the healthcare ecosystem.
Below is the full list of Merck abstracts accepted for presentation at ACTRIMS-ECTRIMS 2020:
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