Date: 2017-11-04
Type of
information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the 2017 ACR/ARHP Annual Meeting
Company: Merck KGaA (Germany)
Product: AS902330 (sprifermin)
Action
mechanism:
- protein. Sprifermin is a truncated recombinant human FGF-18 protein thought to induce chondrocyte proliferation and increased extra-cellular matrix production, with the potential of promoting cartilage growth and repair. The program was originally in-licensed in 2004 from ZymoGenetics, a Bristol-Myers Squibb company.
Disease: primary osteoarthritis of the knee
Therapeutic
area: Inflammatory diseases - Rheumatic diseases
Country: Czechia, Denmark, Estonia, Hong Kong, Poland, Romania, USA
Trial
details:
- This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial. AS902330 (sprifermin) is administered intra-articularly in subjects with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the efficacy and safety of different intra articular dosages of AS902330 in these individuals. Dr. Marc C. Hochberg, Division Head, Rheumatology and Clinical Immunology, University of Maryland School of Medicine is the primary investigator of the study.(NCT01919164)
Latest
news:
- • On November 4, 2017, Merck KGaA announced results of the two-year primary analysis of FORWARD, a five-year, multicenter Phase II study of sprifermin in patients with knee osteoarthritis. The results haveen be presented in a late-breaking oral presentation, “Efficacy and Safety of Intra-Articular Sprifermin in Symptomatic Radiographic Knee Osteoarthritis: Results of the 2-Year Primary Analysis from a 5-Year Randomised, Placebo-Controlled, Phase II Study” at the 2017 ACR/ARHP Annual Meeting in San Diego.
- The study of 549 patients met its primary endpoint, demonstrating statistically- significant, dose-dependent increases in MRI total femorotibial joint cartilage thickness from baseline in the two sprifermin groups receiving the highest doses as compared with the placebo group after the two-year treatment period (+0.03 mm with 100µg sprifermin every six months vs. -0.02 mm with placebo, p<0.001; +0.02 mm with 100µg sprifermin every twelve months vs. -0.02 mm with placebo, p<0.001). Demonstration of an increase in cartilage thickness as opposed to a delay in decreasing cartilage thickness has not been previously reported. The correlation of these changes with clinical endpoints is being evaluated.
- Secondary endpoints included changes in cartilage thickness as measured by MRI in the medial and lateral compartments, as well as changes in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score over two years. Statistically significant treatment effects of increased cartilage thickness were observed in the medial and lateral femorotibial compartments, including the central medial and central lateral regions, in the highest sprifermin dose group. Total WOMAC scores decreased (indicating less symptoms) by approximately 50 percent compared to baseline in all treatment groups, including placebo.
- There was no detectable systemic exposure following the intra-articular injections of sprifermin. Treatment-emergent adverse events were balanced between treatment groups, with musculoskeletal and connective tissue disorders being the most common.
Is
general: Yes
