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Phase III JTA 004 study of JTA 004 fails to meet endpoints in knee osteoarthritis.- Bone Therapeutics

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Published:31st Aug 2021
Bone Therapeutics announced that the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA 004 (hyaluronic acid + analgesic + antiinflammatory) 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 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 3.

Despite JTA 004’s favorable 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 favor 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. The Company, in collaboration with existing and potential partners, will consider the options for the future of JTA 004 development.

JTA 004 is Bone Therapeutics’ next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. It consists of a unique mix of hyaluronic acid - a natural component of knee synovial fluid, plasma proteins, and a fast-acting analgesic. JTA 004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain.

Condition: Pain:Osteoarthritis/ Knee
Type: drug

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