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Press Release

Merck Presents New Osteoarthritis Data at OARSI 2018 World Congress

Merck
Posted on: 18 Apr 18
  • 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

 

Darmstadt, Germany, April 16, 2018 – Merck, a leading science and technology company, 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. Merck’s presence 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. “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 booth at this year’s Congress to learn more about the company's commitment to advancing innovation in OA.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 18/04/2018

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