Merck Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care

Business Wire India

• Company’s scientific management shall be highlighted in 39 abstracts introduced throughout its a number of sclerosis (MS) portfolio
• Data on investigational BTK inhibitor evobrutinib reveal long-term illness stability in folks dwelling with relapsing MS (RMS)
• Phase IV examine highlights enchancment in measures of Quality of Life in folks dwelling with RMS after two years of remedy with MAVENCLAD® (cladribine tablets)

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Merck, a number one science and know-how firm, in the present day introduced it should current 39 abstracts at the 38^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands. The breadth of knowledge highlights the Company’s scientific management in a number of sclerosis (MS) and features a presentation on a medical trial with long-term knowledge on Expanded Disability Status Scale (EDSS) scores in folks with relapsing MS (RMS) handled with evobrutinib, an investigational agent, in addition to new knowledge demonstrating MAVENCLAD^® (cladribine tablets) improved Quality of Life (QoL) in folks with extremely energetic RMS over two years. Additionally, a two-year follow-up examine confirmed the onset of motion on the discount of MRI lesions with MAVENCLAD being maintained from Month 2 by way of two years.

“Multiple sclerosis has a profound affect on high quality of life and bettering this by way of remedy is usually an important final result for folks dwelling with MS,” stated Gavin Giovannoni, Professor of Neurology, Queen Mary University of London. “The knowledge introduced at ECTRIMS additional substantiate the therapeutic profit of MAVENCLAD by bettering Quality of Life measures over two years, mixed with new proof that the early impact on MRI lesions is maintained over that interval.”

In the ultimate evaluation of the open-label, single-arm, multicenter, Phase IV CLARIFY-MS examine, statistically important (p≤0.0001) enhancements from baseline had been noticed for Multiple Sclerosis Quality of Life-54 (MSQoL-54) bodily and psychological well being composite scores (imply modifications of 4.86 and 4.80, respectively; p<0.0001). Changes in MSQoL-54 composite scores had been constant throughout remedy naïve and prior disease-modifying remedy (DMT) subgroups. Annualized relapse fee was 0.13 in all sufferers (0.08 in sufferers who had not acquired DMT prior to receiving MAVENCLAD) and median EDSS was unchanged over two years. No new security issues emerged.

Also to be introduced are new MRI outcomes knowledge from the Phase IV MAGNIFY-MS examine, which demonstrated an onset of motion from Month 2 with sustained discount in MRI lesion counts maintained out to two years in folks with extremely energetic RMS handled with MAVENCLAD. The proportion of lesion-free sufferers elevated from 47% at baseline to 86.2% at the top of the examine (Month 18–24). In the examine, MRI lesions at baseline had been in contrast over a number of time intervals, from preliminary screening to Month 24. Over the 2 years, the profit:danger profile of MAVENCLAD remained unchanged and according to observations made through the medical trial program.

Additionally, up to date post-approval security knowledge shall be introduced primarily based on an evaluation of 56,300 sufferers who acquired MAVENCLAD post-approval, representing 95,664 patient-years of expertise, as of July 2022. The examine discovered the security profile of MAVENCLAD is in keeping with findings from the medical improvement program and the CLARIFY-MS and MAGNIFY-MS research.

“The breadth of our knowledge at ECTRIMS exemplifies our dedication to pushing ahead scientific innovation with the event of evobrutinib, whereas producing new, significant knowledge to reveal the security profile and effectiveness of MAVENCLAD,” stated Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology at Merck. “Our aim is to guarantee folks dwelling with MS, and those that deal with them, have the knowledge they want to handle their MS in the present day and sooner or later.”

Beyond the MAVENCLAD and evobrutinib knowledge introduced, Merck could have a number of Company occasions, together with extra knowledge from its MS portfolio at ECTRIMS 2022.

Company actions at ECTRIMS 2022:

• “Connecting the dots: immune cells and CNS irritation” co-chaired by Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Blizard Institute, Barts and the London School of Medicine and Dentistry, UK, and Celia Oreja-Guevara, MD, PhD, Hospital Clínico San Carlos, Madrid, Spain (October 26, 2022, 13:15-14:15 CEST)
• “New instruments for brand spanking new challenges in a number of sclerosis” chaired by Stephen Krieger, MD, Mount Sinai Hospital, New York, NY, USA (October 28, 2022, 14:15-15:15 CEST)
• Product Theater: Early Experience with MAVENCLAD by Ravi Dukkipati, MD, WellSpan Neurology, York, PA, USA

To sustain to date with our actions at ECTRIMS together with future knowledge and knowledge, go to merckneurology.com/newsroom or comply with us on Twitter @MerckHealthcare and LinkedIn: Healthcare Business of Merck

Below is the complete record of Merck-related abstracts accepted for presentation at ECTRIMS 2022:

About Evobrutinib
Evobrutinib is an oral, extremely selective CNS-penetrant inhibitor of Bruton’s tyrosine kinase (BTK) in medical improvement as a possible remedy for relapsing a number of sclerosis (RMS). It is the primary BTK inhibitor to reveal medical efficacy within the largest Phase II examine with follow-up past three years in addition to reveal an affect on early biomarkers of ongoing central irritation that correlate with illness development. Evobrutinib is designed to modulate B cell responses resembling proliferation and antibody and cytokine launch, in addition to modulate macrophage/microglia activation. It considerably lowered SEL quantity and ranges of blood NfL, markers of ongoing central irritation and neurodegeneration that predict long-term incapacity. Evobrutinib was optimized for efficacy by way of probably the most complete BTK inhibitor dose-finding examine in RMS which demonstrated 75mg twice-daily dosing achieves maximal efficacy throughout endpoints by sustaining BTK inhibition all through the dosing interval (>95% BTK occupancy maintained in 98% of sufferers earlier than subsequent dose). It is at the moment underneath medical investigation and isn’t authorized for any use wherever on this planet.

About MAVENCLAD^®
MAVENCLAD, authorized by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the primary and solely short-course oral remedy for the remedy of adults with relapsing-remitting illness (RRMS) and energetic secondary progressive illness (SPMS). Because of its security profile, use of MAVENCLAD is mostly advisable for sufferers who’ve had an insufficient response to, or are unable to tolerate, an alternate drug indicated for the remedy of a number of sclerosis (MS), and MAVENCLAD will not be advisable to be used in sufferers with clinically remoted syndrome (CIS). Patients ought to comply with healthcare supplier directions together with most cancers screening, contraception and blood assessments. The authorized dose of MAVENCLAD is 3.5 mg per kg physique weight over two years, administered as one remedy course of 1.75 mg per kg per 12 months, every consisting of two remedy weeks. The mechanism by which cladribine exerts its therapeutic results in sufferers with a number of sclerosis has not been totally elucidated however is believed to contain cytotoxic results on B and T lymphocytes by way of impairment of DNA synthesis, leading to depletion of lymphocytes. MAVENCLAD causes a dose-dependent discount in lymphocyte counts adopted by restoration.

Because cladribine is cytotoxic, particular dealing with and disposal directions ought to be adopted.

MAVENCLAD has been authorized in over 80 international locations, together with the European Union (EU), Canada, Australia and Switzerland, for varied relapsing MS indications. Visit www.MAVENCLAD.com for extra data.

About Rebif^®
Rebif (interferon beta-1a) is indicated for the remedy of relapsing kinds of a number of sclerosis (MS), to embody clinically remoted syndrome, relapsing-remitting illness, and energetic secondary progressive illness, in adults. It is used to lower the frequency of relapses and delay the prevalence of some of the bodily incapacity that’s frequent in folks with MS.

About Multiple Sclerosis
Multiple sclerosis (MS) is a power, inflammatory situation of the central nervous system and is the commonest non-traumatic, disabling neurological illness in younger adults. It is estimated that roughly 2.8 million folks have MS worldwide. While signs can fluctuate, the commonest signs of MS embody blurred imaginative and prescient, numbness or tingling within the limbs and issues with energy and coordination. The relapsing kinds of MS are the commonest.

Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with important R&D and business expertise in a number of sclerosis (MS). The firm’s present MS portfolio contains two merchandise for the remedy of relapsing MS – Rebif^® (interferon beta-1a) and MAVENCLAD^® (cladribine tablets). Merck goals to enhance the lives of sufferers by addressing areas of unmet medical wants. In addition to Merck’s dedication to MS, the corporate additionally has a pipeline specializing in discovering new therapies which have potential in different neuroinflammatory and immune-mediated ailments, together with systemic lupus erythematosus (SLE), generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum dysfunction (NMOSD).

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About Merck
Merck, a number one science and know-how firm, operates throughout life science, healthcare and electronics. Around 60,000 staff work to make a constructive distinction to hundreds of thousands of folks’s lives day by day by creating extra joyful and sustainable methods to dwell. From advancing gene modifying applied sciences and discovering distinctive methods to deal with probably the most difficult ailments to enabling the intelligence of gadgets – the corporate is in all places. In 2021, Merck generated gross sales of € 19.7 billion in 66 international locations.

Scientific exploration and accountable entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding household stays the bulk proprietor of the publicly listed firm. Merck holds the worldwide rights to the Merck identify and model. The solely exceptions are the United States and Canada, the place the business sectors of Merck function as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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