Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS
Merck, a leading science and technology company, will present data from a Phase II placebo-controlled randomized trial at the 2021 American Academy of Neurology (AAN) Annual Meeting showing that the investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib significantly reduced blood neurofilament light chain (NfL) levels, a key biomarker of neuronal damage and inflammation, in patients with multiple sclerosis (MS). Elevated blood NfL levels have been shown to be associated with damage to neurons and inflammation and may predict future brain atrophy and disease progression.
“Blood NfL is a biomarker that may allow monitoring of disease activity and treatment response, which could be less burdensome and more sensitive than other standard clinical measures for MS patients,” said Prof. Jens Kuhle, MD, PhD, Head Multiple Sclerosis Centre, University Hospital Basel. “These data provide key insights into the role evobrutinib may play in modulating the clinical course of MS and further suggest that BTK inhibition with evobrutinib may reduce tissue damage associated with MS.”
A post-hoc analysis of the Phase II placebo-controlled trial of evobrutinib in patients with relapsing MS (RMS) evaluated 166 patients with NfL values at baseline and at least one post-baseline. The largest relative reductions of NfL levels were observed with evobrutinib 75mg twice daily (BID) at weeks 12 and 24 compared to placebo. Twice daily dosing with an exposure equivalent to 75mg twice daily is being carried through to the Phase III program which is on track to complete enrollment this year. Primary results from the Phase II study were previously published in the New England Journal of Medicine in 2019. As elevated NfL is associated with clinical disability and brain atrophy in MS, these results, combined with the previous clinical trial data that demonstrated a reduction in T1 Gd+ lesion and ARR, further support the hypothesis that BTK inhibition with evobrutinib may impact both inflammatory and progressive aspects of MS within the central nervous system (CNS).
Further supporting the impact of evobrutinib on CNS pathology in MS, a second oral presentation at AAN examined BTK and activated (phosphorylated) BTK (pBTK) levels in B cells isolated from RMS patients. pBTK was highly expressed in subsets of B cells of RMS patients, including T-bet and CXCR3 expressing memory B cells. Evobrutinib decreased CXCR3+ memory B cell transmigration through human CNS endothelial cell monolayers, suggesting evobrutinib may impact the activity of pathogenic B cells and modulate the progressive course of MS.
“Taken together, the presented pre-clinical and clinical data suggest that evobrutinib inhibits MS mechanisms involved in disease activity and progression,” said Danny Bar-Zohar, MD, Global Head of Development, Healthcare business of Merck. “Coupled with the already published and presented attributes of CNS penetration as well as very high BTK occupancy, these findings further substantiate the strong potential for evobrutinib to lead to a paradigm shift in the treatment of people living with MS.”
Separately, an exploratory analysis to be presented at the upcoming triMS.online conference on 27 May evaluated evobrutinib distribution into cerebrospinal fluid (CSF) relative to plasma concentration in patients with RMS. Plasma and CSF samples were collected from a subset of MS patients in the Phase II open-label extension (OLE) study receiving 75mg BID. Evobrutinib was detected in the CSF of all patients included in the analysis (n=9). CSF concentrations were generally consistent with free plasma concentrations. This suggests that evobrutinib, in addition to inhibiting BTK on peripheral cells, may also inhibit BTK-expressing B cells and myeloid cells in the CNS, which may impact MS disease progression.
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton’s tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck`s commitment to MS, the company also have a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).
All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Electronics.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Tone Brauti Fritzen
+49 151 1454 2694
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Data From Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 EHA Virtual Congress12.5.2021 22:18:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) 2021 Virtual Congress, held virtually from June 9-17, 2021. “We are pleased that data highlighting the strength of Incyte’s oncology portfolio and partner-sponsored programs will be presented at this year’s EHA Virtual Congress,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. “In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our JAK1/JAK2 inhibitor; and an ePoster from our Phase 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis – reinforce our commitment to finding solutions for patients with significant unmet medical needs.” Key abstracts ac
Monument Assurance Luxembourg Acquires AME Life Luxembourg ("AMELL") From Covéa12.5.2021 21:55:00 CEST | Press release
Monument Re announced today that, subject to necessary regulatory approval, Monument Assurance Luxembourg will acquire AME Life Luxembourg (“AMELL”) from French Mutual Insurance Group Covéa. AMELL is a well-established Luxembourg-based life insurance company with market presence in Luxembourg, Belgium and Italy. Financial terms of the transaction were not disclosed. The transaction will have no impact on AMELL clients and policyholders. “We are pleased to have reached agreement with Covéa to acquire its subsidiary AMELL. This transaction represents an important step in our consolidation strategy by further strengthening our presence in Luxembourg,” said Manfred Maske, CEO of Monument Re. Change of control of the company will follow satisfaction of customary closing conditions, including receipt of regulatory approvals. For further information: To learn more, please visit our website at www.monumentregroup.com or contact Fiona Davies at email@example.com, +1(441) 400-9300. Monume
Raven Industries Launches the OMNi Brand12.5.2021 15:15:00 CEST | Press release
Raven Industries, Inc.(the Company; NASDAQ:RAVN) a leader in agriculture technology, announced today the launch of its new product brand and autonomous growth platform, OMNi. This new product brand highlights Raven’s advancements in autonomous solutions for agriculture with a strategic offering of two integrated products: OMNiDRIVE™ and OMNiPOWER™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210512005126/en/ The OMNi name (meaning "all") will take center stage within Raven. “Empowering ‘all’ is exactly what OMNiPOWER™ and OMNiDRIVE™ bring to the agriculture industry. OMNi enables holistic, hands-free precision; it gives the farmer total control of their time and maximizes operational productivity and efficiency,” said Nick Langerock, Director of Strategic Marketing for Raven. “As we bring OMNi to market, we want farmers to understand that some of their pain points are now more manageable through autonomous solutions. OMNi
SentinelOne Receives Highest Score for the Type A Use Case (“Lean Forward” Organizations) in the Gartner 2021 Critical Capabilities for Endpoint Protection Platforms12.5.2021 15:00:00 CEST | Press release
SentinelOne, the autonomous cybersecurity platform company, today announced that Gartner has positioned SentinelOne with the highest score in use case Type A in Gartner’s 2021 Critical Capabilities for Endpoint Protection Platforms report1. SentinelOne received the highest score for all three customer types out of 19 vendors. Gartner says, “Type A organizations, also referred to as 'lean forward' organizations, adopt new technologies very early in the adoption cycle.” “We believe receiving the highest product score among early technology adopters in the 2021 Critical Capabilities for Endpoint Protection Platforms validates our commitment to disrupt and broaden the endpoint space,” said Raj Rajamani, Chief Product Officer, SentinelOne. “These organizations tend to focus on innovative solutions that address their business, technology and security needs. Receiving the highest score for 'lean forward' companies highlights our ability to take cybersecurity defenses to new levels of speed, e
New CloudBlue Revenue Management Solution Solves for Recurring Billing Reconciliation12.5.2021 15:00:00 CEST | Press release
CloudBlue, a leading cloud ecosystem technology company, announced today the launch of CloudBlue Rev, a solution that enables partners to ‘rev’ up their channel revenue management. CloudBlue Rev simplifies and streamlines channel revenue management to enhance efficiency, save time and increase profitability. Available now in the United Kingdom with planned rollouts across the world, learn more here. The new solution is based on the recently acquired HarmonyPSA architecture and is the latest addition to CloudBlue’s rapidly expanding portfolio of technologies and services for the channel. CloudBlue Rev helps channel reseller partners regain valuable time as they transition to an everything-as-a-service business by automating quoting, billing and reconciliation. By streamlining these processes into a single platform, resellers will now be able to automate profit tracking across sales motions with integrated discounting and markup, as well as quickly set margins and gain insight into contr
Hiro Capital Leads $6.4m Investment in Game Innovators Twin Suns Corp and FRVR12.5.2021 15:00:00 CEST | Press release
Twin Suns Corp and FRVR will use Hiro’s $6.4m of investment to expand development and to accelerate growth. Twin Suns Corp is a new AAA-game studio, founded by >20-year industry veterans - Tim Longo Jr. (Star Wars: Republic Commando, Halo, Tomb Raider), Forest Swartout Large (Hitman and Tomb Raider), and Jeff Morris (Gears of War and Unreal Tournament). Twin Suns Corp is building a next-gen AAA cross-platform title that will launch an exciting new IP franchise; with additional team members that have worked on Star Wars, Tomb Raider, Hitman, Halo, Elder Scrolls, Fallout, Gears of War, Unreal Tournament and Avengers. FRVR is an instant games ecosystem platform powering frictionless game play on any device, founded by Chris Benjaminsen (Yahoo, PlayerScale) and Brian Meidell (Cape, GameAnalytics) With more than 1bn players, FRVR has partnerships that puts their tech and games onto billions of devices. Twin Suns Corp and FRVR join other creator-founded Games teams Polyarc, Snowprint, Lightf
Nuclera Acquires E Ink Digital Microfluidics Unit12.5.2021 14:53:00 CEST | Press release
Nuclera, a fast-growing biotech company developing enzymatic protein and gene synthesis technologies, and E Ink, the leading innovator of electronic ink technology, are pleased to announce the acquisition of E Ink’s digital microfluidics unit into the newly formed US subsidiary of Nuclera. Combining the technologies of the two companies will enable the delivery of a revolutionary desktop protein and gene “bioprinter” with breakthrough speed and convenience for researchers in human health, agriculture, and other markets of global importance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210512005575/en/ Nuclera desktop bioprinter powered by digital microfluidic technology. (Photo: Business Wire) Nuclera has been working in a strategic partnership with E Ink since 2018 to deploy Nuclera’s proprietary biopolymer synthesis technologies on E Ink’s digital microfluidic devices. Instead of the physical channels found in convention