Merck has announced results from FORWARD, a five-year, multicentre Phase II study of sprifermin in symptomatic radiographic knee osteoarthritis (OA).
The treatment, a recombinant human fibroblast growth factor-18, showed statistically significant, dose-dependent increases in total femorotibial joint cartilage thickness compared to both baseline and placebo comparator.
The company announced that the results, published online in the Journal of the American Medical Association (JAMA), were based on the two-year primary outcome and the three-year, follow-up analysis from the trial.
In the study of 549 patients, the primary endpoint was met and at the two-year treatment point, a mean increase in cartilage thickness was observed in the two sprifermin groups receiving the highest doses.
“The publication of these clinical data assessing therapeutic intervention for osteoarthritis in the Journal of the American Medical Association and at the upcoming American College of Rheumatology Annual Meeting are noteworthy,” said Luciano Rossetti, global head of research & development at the Biopharma business of Merck.
He continued, “This represents an area of significant medical need, as osteoarthritis is a degenerative condition with no approved treatment options that directly target structural disease progression.”
There are approximately 237 million people worldwide living with symptomatic and activity-limiting OA, the third most rapidly rising condition associated with disability globally.
Currently there are no approved drugs for preventing or slowing disease progression.