Bone Therapeutics Breaks After Phase III Osteoarthritis Failure

Knee Pain

Shares of Belgium-based Bone Therapeutics are down more than 34% on the Euronext stock exchange after the company announced its Phase III osteoarthritis study using its enhanced viscosupplement JTA-004 failed to meet primary and critical secondary endpoints.

Bone Therapeutics is attempting to develop a next-generation intra-articular injectable to treat osteoarthritic pain in the knee. The Phase III study assessed JTA-004, which is being developed to provide additional lubrication and protection to the cartilage of the arthritic knee joint in an attempt to alleviate osteoarthritic pain. Bone Therapeutics’ experimental asset consists of a mix of hyaluronic acid, plasma proteins and a fast-acting analgesic.

In this particular placebo-controlled study, JTA-004 was assessed to relieve osteoarthritic knee pain as measured by the WOMAC pain subscale three months after treatment. A key secondary objective was a three-month comparison between JTA-004 and Hylan G-F 20, a commonly used intra-articular injection for osteoarthritic knee pain. Bone Therapeutics said JTA-004 failed to demonstrate a statistically significant difference in pain reduction against both placebo and the comparator drug in the study.

While the company noted that all treatment arms showed similar efficacy, Bone Therapeutics did say a post-hoc analysis revealed a statistically significant difference in favor of JTA-004 and the active comparator versus placebo in a subset of patients who had higher pain scores at the start of the trial.

Despite the trial failure, Dr. Miguel Forte, chief executive officer of Bone Therapeutics, called the execution of the Phase III study “flawless.” Forte expressed disappointment at the efficacy outcome of the study but noted the favorable safety profile for JTA-004.

“Knee osteoarthritis studies are recognized across the industry to be challenging to evaluate. They are also frequently complicated by a high placebo effect. We will continue to analyze the data and will consider potential next steps,” Forte said in a statement.

The future of JTA-004 development will be decided by Bone Therapeutics and its collaborating partners. Until then, Forte said the company is fully committed to developing its advanced MSC allogeneic cell and gene therapy platform.

“Bone Therapeutics is concentrating on the development of this platform for the large market of orthopedic indications, with ALLOB. The progress with this platform has enabled us to expand it to other indications, including immunomodulation,” Forte added.

ALLOB is being assessed in a Phase IIB study with fresh tibial fractures at risk of delayed or non-union. The study will examine the potential for a single injection of ALLOB as a treatment that can accelerate fracture healing and prevent late-stage complications in these patients. Topline results from the IIb study are expected in the first half of 2022. However, Bone Therapeutics said that is subject to change due to the ongoing COVID-19 pandemic.

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