Pursuing Novel Pathways in Immunology: Merck KGaA, Darmstadt, Germany Presents New Clinical Data at 2017 ACR/ARHP Annual Meeting
DARMSTADT, Germany, Oct. 20, 2017 /PRNewswire/ -- Merck KGaA, Darmstadt, Germany, a leading science and technology company which operates its healthcare business in the U.S. and Canada as EMD Serono, today announced 11 abstracts are scheduled for presentation in oral and poster sessions, including one late-breaker, at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting to be held November 3-8, 2017 in San Diego, CA, U.S. This data reflects the company's resolute drive to pursue novel pathways and address areas of high unmet medical need for patients with chronic progressive diseases, particularly those of the immune system.
Noteworthy data includes a late-breaking abstract on FORWARD, a five-year Phase II study of sprifermin in OA of the knee, providing insights into its potential disease-modifying properties.
Additional data includes an oral presentation on the investigational agent atacicept in a subset of patients with high disease activity based on a post-hoc analysis of ADDRESS II, a 24-week, randomized, placebo-controlled Phase IIb study.
"We are committed to discovering and delivering transformative treatments to significantly improve the lives of people living with chronic progressive diseases," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. "Our approach has led to the discovery of novel pathways that modulate the immune system in more targeted ways, based on preclinical models. We're proud to showcase the progress we've made as we continue to explore the potential of these compounds that may eventually alter treatment paradigms."
Other data of note include an updated safety analysis of ADDRESS II and its long-term extension study; an exposure-response and exposure-safety modeling analysis of ADDRESS II and the Phase II APRIL-SLE study; an in-vitro study of abituzumab for potential use in fibrotic diseases (or fibrosis); and a pharmacodynamics (PD) modeling study of evobrutinib, one of the first Bruton's Tyrosine Kinase Inhibitors to be studied as a potential treatment in autoimmune diseases, with potential for eventual use in RA and SLE. All agents are investigational and have not been proven safe or effective, and are not registered in any market.
Accepted key abstracts at the 2017 ACR/ARHP Annual Meeting include:
Title Presenting Author Abstract Number Presentation Date/Time Session Type/Title
----- ----------------- --------------- ---------------------- ------------------
Sprifermin
----------
Efficacy and Safety of Intra- Tuesday, November 7, 4:30 PM -
Articular Sprifermin in 6:00 PM PT
Symptomatic Radiographic
Knee Osteoarthritis: Results
of the 2-Year Primary
Analysis from a 5-Year
Randomised, Placebo-
Controlled, Phase II Study M Hochberg 1L ACR Late-Breaking Abstract Session
----------------------------- ---------- --- ------------------------------- ----------------------------------
Clinical Relevance of C Kwoh 1207 Monday, November 6, 9:00 AM - ACR Poster Session B: Osteoarthritis -
Structural Measures in Knee 11:00 AM PT Clinical Aspects Poster I: Clinical
Osteoarthritis: Trials and Interventions
Baseline Values and Change from Baseline Discriminate Patients
Subsequently Receiving Knee Replacement
--------------------------------------- ---
Two-Year Changes in Knee C Kwoh 2183 Tuesday, November 7, 9:00 AM - ACR Poster Session C: Osteoarthritis -
Osteoarthritis Symptoms: 11:00 AM PT Clinical Aspects Poster II:
Comparing Observational and Epidemiological
Studies
Clinical Relevance of Patient-Reported Outcomes By Anchoring
to Knee Replacement
------------------------------------------------------------ ---
Atacicept
---------
Attainment of Low Disease Sunday, November 5, 2:30 PM - 4:00 ACR Concurrent Abstract Session - Oral
Activity By Patients with PM PT Presentation: Systemic Lupus
Systemic Lupus Erythematosus Erythematosus - Clinical Aspects and
(SLE) Starting with High Treatment I: Novel and Current
Disease Activity in a 24- Therapies
Week, Randomized, Placebo-
Controlled, Phase IIb Study
of Atacicept (ADDRESS II) J Merrill 889
----------------------------- --------- --- ---------------------------------- --------------------------------------
Safety Profile in SLE Tuesday, November 7, 9:00 AM - ACR Poster Session C: Systemic Lupus
Patients Treated with 11:00 AM PT Erythematosus - Clinical Aspects and
Atacicept in a Phase IIb Treatment Poster III: Therapeutics
Study (ADDRESS II) and Its and Clinical Trial Design
Extension Study J Merrill 2585
--------------------------------------------------------------- --------- ---- ------------------------------- -------------------------------------
Exposure-Response Modeling O Papasouliotis 2586 Tuesday, November 7, 9:00 AM - ACR Poster Session C: Systemic Lupus
and Exposure-Safety 11:00 AM PT Erythematosus - Clinical Aspects and
Modeling Treatment Poster III: Therapeutics
and Clinical Trial Design
Analyses in Two Phase II Studies of Atacicept in SLE
-------------------------------------------- ---
QuantiFERON Testing in a N Goel 2610 Tuesday, November 7, 9:00 AM - ACR Poster Session C: Systemic Lupus
Clinical Trial of Systemic 11:00 AM PT Erythematosus - Clinical Aspects and
Lupus Erythematosus: TB or Treatment Poster III: Therapeutics
Not TB and Clinical Trial Design
--------------------------- ------ ---- ------------------------------- -------------------------------------
Abituzumab
----------
The V Integrin Inhibitor E Samy 774 Sunday, November 5, 9:00 AM - ACR Poster Session A: Systemic
Abituzumab Inhibits 11:00 AM PT Sclerosis, Fibrosing Syndromes and
Myofibroblast Raynaud's - Pathogenesis, Animal
Differentiation Models and Genetics Poster I
------------------------- ------ --- ------------------------------ -----------------------------------
Evobrutinib
-----------
Pharmacodynamic Modeling of Tuesday, November 7, 9:00 AM - ACR Poster Session C: Systemic Lupus
BTK Occupancy Versus 11:00 AM PT Erythematosus - Animal Models Poster
Efficacy in RA and SLE
Models Using the Novel
Specific BTK Inhibitor
Evobrutinib P Haselmayer 2565
--------------------------- ------------ ---- ------------------------------- -------------------------------------
Discovery Products
------------------
A novel role for galectin-3 Sunday, November 5, 9:00 AM - ACR Poster Session A: B Cell Biology
binding protein in B cell 11:00 AM PT and Targets in Autoimmune Disease
biology and antibody Poster
secretion S Okitsu 25
--------------------------- -------- --- ------------------------------ -------------------------------------
Assessing interferon Monday, November 6, 9:00 AM - ACR Poster Session B: Innate Immunity
regulatory factor 5 (IRF5) 11:00 AM PT and Rheumatic Disease Poster II
function in human primary
immune cells with cell-
penetrating peptides G Chen 1060
--------------------------- ------ ---- ------------------------------ --------------------------------------
For more information about the data to be presented, please visit the ACR/ARHP website. Also, visit the EMD Serono booth at this year's Annual Meeting to learn more about the company's commitment to advancing innovation in immunological diseases.
About Atacicept
Atacicept is in clinical development to investigate its potential as a treatment for systemic lupus erythematosus (SLE). It is a recombinant fusion protein which targets the cytokines APRIL and BlyS, two members of the tumor necrosis factor family that regulates B-cell maturation, function and survival and autoantibody production associated with certain autoimmune diseases such as SLE. Atacicept has been shown in animal models to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies. It is currently in Phase II studies.
About Sprifermin
Sprifermin is in clinical development to investigate its potential as a treatment for osteoarthritis (OA) in the knee. It is a truncated recombinant human FGF-18 protein thought to induce chondrocyte proliferation and increased extra-cellular matrix (ECM) production, with the potential of promoting cartilage growth and repair. Sprifermin is currently in Phase II studies.
About Abituzumab
Abituzumab is in clinical development to investigate its potential as a treatment for fibrotic diseases (or fibrosis). It is a recombinant de-immunized humanized IgG2 monoclonal antibody (mAb) that inhibits all subtypes of v integrins. Abituzumab is designed to block integrin-mediated activation of latent TGF- and prevent fibroblast-to-myofibroblast transition, a key event in fibrosis. It is currently in Phase II studies.
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). 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 in Phase II studies.
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About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany, generated sales of EUR 15.0 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the "Merck" name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
About EMD Serono, Inc.
EMD Serono is the biopharma business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.
http://www.emdserono.com
ACR Abstract #
Atacicept: 889, 2585, 2586, 2610; Sprifermin: 1207, 2183, 1L; Abituzumab: 774; Evobrutinib: 2565; Discovery Products: 25, 1060
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