Merck KGaA, Darmstadt, Germany, Presents New Osteoarthritis Data at OARSI 2018 World Congress
Merck KGaA, Darmstadt, Germany today announced 16 abstracts, including two oral presentations, will be presented at the Osteoarthritis Research Society International (OARSI) 2018 World Congress, held April...
- Company to present 16 abstracts highlighting the momentum of its progress in osteoarthritis (OA) research and showcasing the company’s leading OA pipeline
- Oral presentations on sprifermin offer further insights supporting its dose-response structural effect in patients with knee OA, observed in earlier studies
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 16 abstracts, including two oral presentations, will be presented at the Osteoarthritis Research Society International (OARSI) 2018 World Congress, held April 26-29, 2018 in Liverpool, United Kingdom. The presence of Merck KGaA, Darmstadt, Germany at OARSI reflects the company’s dedication to helping optimize outcomes for patients living with chronic progressive diseases, with the goal of developing novel disease-modifying therapies for osteoarthritis (OA).
Data of note includes an oral presentation of the three-year analysis of FORWARD, a five-year, multicenter Phase II study of sprifermin in OA of the knee. Results were consistent with the two-year results, which showed a statistically significant dose-dependent increase in cartilage thickness in total, lateral and medial femorotibial compartments as compared to placebo treatment, based on quantitative magnetic resonance imaging (qMRI). At year three, which was eighteen months after the last treatment cycle, cartilage thickness declined in all treatment arms as compared to year two. However, the difference observed at year two with sprifermin at the highest dose and frequency versus placebo was maintained at year three. The safety profile at year three was consistent with results observed at year two, where treatment emergent adverse events were balanced between groups and musculoskeletal and connective tissue disorders the most common.
“These data suggest the structural benefit of sprifermin at the highest dose was maintained in the third year and its long-term potential as a disease-modifying treatment for osteoarthritis will continue to be explored," said Dr. Marc C. Hochberg, primary investigator of the FORWARD study and Division Head, Rheumatology and Clinical Immunology, University of Maryland School of Medicine. "Osteoarthritis impacts an estimated 10 percent of the world’s population over the age of 601 and represents an area of high unmet need for disease-modifying treatment options.”
A second oral presentation features the results of an ex vivo study that showed sprifermin induced extra-cellular matrix remodelling and cartilage regeneration. In the study, long-term treatment with sprifermin continuously increased metabolic activity and type II collagen formation in human OA articular cartilage compared with placebo.
“We are committed to helping patients with osteoarthritis by elevating our understanding of the disease and continuing to invest in highly-targeted therapies,” said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. “Our intent is to provide true advancement to the field of osteoarthritis by developing therapeutic options with disease-modifying potential.”
Additional presentations include: pre-clinical data for M6495, an ADAMTS-5 inhibiting nanobody moving into Phase I clinical development for OA; pre-clinical data for M1673, a GDF5 mutant for the potential treatment of OA; and research related to improving measures and patient recruitment in OA studies.
Accepted abstracts at the OARSI 2018 World Congress include:
Title |
Presenting Author |
Abstract Number |
Presentation Date/Time |
Session Type/Title |
Sprifermin |
||||
Efficacy and Safety of Intra-Articular Sprifermin in Symptomatic Radiographic Knee Osteoarthritis: Pre-Specified Analysis of 3-Year Data From a 5-Year Randomized, Placebo-Controlled, Phase II Study with a 2 Year Treatment Phase |
M Hochberg |
32 |
Friday, April 27, 2:30 PM – 4:00 PM |
Concurrent Session 3 – OA Clinical Trials and Treatment (Oral) |
Articular Cartilage from OA Patients Show Extracellular Matrix Remodelling Over the Course of Treatment with Sprifermin (Recombinant Human Fibroblast Growth Factor 18) |
A Bay-Jensen |
65 |
Saturday, April 28, 10:45 AM – 12:15 PM |
Plenary Session 5 – Growth Factors in OA: Opportunities for Intervention (Oral) |
Intra-Articular Sprifermin Reduces Cartilage Loss in Addition to Increasing Cartilage Gain Independent of Femorotibial Location: A Post Hoc Analysis of a Randomized, Placebo-Controlled Phase II Clinical Trial |
F Eckstein |
551 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3 |
M6495 (ADAMTS-5) |
||||
In Vitro Characterization of the ADAMTS-5 Specific Nanobody M6495 |
D Werkmann |
346 |
Friday, April 27, 12:30 -1:00 PM & 4:30-5:00 PM
Saturday, April 28, 4:15 – 5:00 PM |
Poster Sessions 1-3
|
Structural and Symptomatic Benefit of a Half-Live Extended Systemically Applied Anti-ADAMTS-5 Inhibitor M6495 |
C Brenneis |
563 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Pharmacokinetic and Pharmacodynamic Modelling of the Novel Anti-ADAMTS-5 Nanobody M6495 Using the Neo-Epitope Args as a Biomarker |
J Pereira |
343 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
The Anti-ADAMTS-5 Nanobody, M6495, Protects Against Cartilage Breakdown in Cartilage and Synovial Joint Tissue Explant Models |
A Siebuhr |
363 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Study Design of a Phase I, Placebo-Controlled, First-In-Human Trial To Assess Safety and Tolerability, Immunogenecity, and Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of the Anti-ADAMTS-5 Nanobody, M6495, in Healthy Male Subjects |
A Bihlet |
522 |
Friday, April 27, 12:30 -1:00 PM & 4:30-5:00 PM
Saturday, April 28, 4:15 – 5:00 PM |
Poster Sessions 1-3
|
M1673 (GDF5 mutant) |
||||
M1673 (GDF5 mutant) Increases Matrix Production in Primary Porcine and Human Osteoarthritic Chondrocytes |
T Mang |
138 |
Friday, April 27, 12:30 -1:00 PM & 4:30-5:00 PM
Saturday, April 28, 4:15 – 5:00 PM |
Poster Sessions 1-3
|
A GDF5 Mutant Induces Chondrogenesis in Mesenchymal Stem Cells Similarly to GDF5 Wildtype But Shows a Decreased Osteogenic Potential |
T Mang |
125 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Osteoarthritis Research |
||||
C1M, C2M, C3M, PRO-C2, and CRPM in Serum Reflect Different Potential Pathogenetic Domains of Osteoarthritis, Data from Check |
A Bay-Jensen |
349 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Recruitment Procedure Maximising Inclusion of Progressors in OA Clinical Studies Based on Existing Cohorts: Approach-Consortium Data Analysis |
P Widera |
521 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Data Harmonisation for Machine Learning Model in APPROACH-consortium: Development to Predict Osteoarthritis Progression in Patients across Populations |
P Widera |
519 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
"APPROACH” Study: A 2-Year, European, Cohort Study to Describe, Validate and Predict Phenotypes of Knee Osteoarthritis By Use Of Clinical, Imaging and Biochemical Markers |
E van Helvoort |
515 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
Two Year Tibiofemoral Joint Cartilage Loss is Weakly Correlated With Increased Pain Among Knees With Lower Baseline Cartilage Thickness |
C Kwoh |
474 |
Friday, April 27, 12:30 -1:00 PM & 4:30-5:00 PM
Saturday, April 28, 4:15 – 5:00 PM |
Poster Sessions 1-3
|
Pain Medication Reporting and Patient-Reported Outcomes in the Years Prior to Knee Replacement: Challenges to Assessing Symptomatic Experiences |
C Kwoh |
455 |
Friday, April 27, 12:00-12:30 PM & 4:00-4:30 PM
Saturday, April 28, 3:30-4:15 PM |
Poster Sessions 1-3
|
For more information about the data to be presented, please access the OARSI app. Also, visit the Merck KGaA, Darmstadt, Germany booth at this year’s Congress to learn more about the company’s commitment to advancing innovation in OA.
Downloads
-
OARSI-Curtain-Raiser-US.pdf
All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 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 2021, Merck KGaA, Darmstadt, Germany, generated sales of € 19.7 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
Related News
-
Press Releases
Pimicotinib Significantly Improved Outcomes for Patients with TGCT in Phase ...
Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate in TGCT-patients.
2024/11/12