Bone Therapeutics knee osteoarthritis Phase III study misses primary endpoints
pharmafile | August 31, 2021 | News story | Manufacturing and Production |
Bone Therapeutics, the cell therapy company addressing unmet medical needs in orthopaedics and other diseases, announced that the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 did not meet the primary and consequently the key secondary endpoints.
The primary objective of the JTA-004 Phase III study was to demonstrate the efficacy of JTA-004 in reducing osteoarthritic knee pain compared to placebo as measured by the WOMAC(R) pain subscale three months after treatment.
A key secondary objective was the comparison between JTA-004 and comparator Hylan G-F 20 in knee pain relief at month three.
Despite JTA-004’s favourable safety profile, the study did not achieve its main objectives as no statistically significant difference in pain reduction could be observed between any of the treatment, placebo and comparator groups, with all treatment arms showing similar efficacy.
A statistically significant difference in favour of JTA-004 and the active comparator versus placebo was seen in a post-hoc analysis in a subset of patients with higher pain scores at entry.
Bone Therapeutics, in collaboration with existing and potential partners, will consider the options for the future of JTA development.
Miguel Forte, Chief Executive Officer of Bone Therapeutics, said: “The execution of the study was flawless and a good safety profile was observed in line with previous results. These JTA efficacy results are disappointing.
“Knee osteoarthritis studies are recognised across the industry to be challenging to evaluate. They are also frequently complicated by a high placebo effect. We will continue to analyse the data and will consider potential next steps.
“We are now fully committed to the clinical development of our advanced MSC allogeneic cell and gene therapy platform. Bone Therapeutics is concentrating on the development of this platform for the large market of orthopaedic indications, with ALLOB. The progress with this platform has enabled us to expand it to other indications, including immunomodulation.”
Lilly Subbotin
