June 12, 2020

Intra-Articular Injection of JTA-004 Improves Pain Related to Knee Osteoarthritis

By Eric Ramos

CHICAGO -- June 12, 2020 -- An intra-articular injection of JTA-004, a novel enhanced protein solution that is supplemented with hyaluronic acid and clonidine, improved pain in patients with knee osteoarthritis, according to a study presented at the 2020 Virtual Meeting of the European League Against Rheumatism (EULAR).

“Osteoarthritis is associated with chronic pain, joint function impairments ,and disabilities, causing a poorer quality of life with physical and/or mental comorbidity,” said Marie Bettonville, Bone Therapeutics S.A., Gosselies, Belgium. “Along with population ageing and increasing obesity, the incidence of osteoarthritis is rising and there is an urgent need for new treatment options.”

For the study, the researchers randomised 164 patients aged 50 to 79 years with primary knee osteoarthritis to receive a single dose of 1 of 3 JTA-004 formulations or to Hylan G-F 20. The 3 JTA-004 formulations differed in their clonidine concentration (50 or 100 µg/ml) and/or their volume of injection (2 or 4 ml).

At 6 months, patients in the 3 JTA-004 groups showed a better improvement in pain compared with patients who received Hylan G-F 20. The between-group difference (between each JTA-004 test group and the Hylan group) in adjusted mean change in Western Ontario McMaster Universities (WOMAC) pain subscale Score from baseline ranged between -9.49 mm and -11.63 mm at 6 months post-injection. However, statistical superiority of each of the JTA-004 formulations over Hylan G-F 20 was not demonstrated.

As the 3 JTA-004 formulations had a similar efficacy in terms of pain reduction, a post hoc analysis was subsequently performed between the pooled JTA-004-treated patients and the reference group. Results of the analysis showed a statistically significant improvement in pain in the pooled JTA-004 group (mean 26.1 ± 2.4 mm) compared with the control group at 6 months (15.6 ± 4.1 mm; P = .030).

“All JTA-004 formulations were shown to be well tolerated and had a clinically acceptable safety profile, with no cases of post-injection mild and transient hypotension,” said Bettonville.

[Presentation title: Efficacy and Safety of An Intra-Articular Injection of JTA-004, a Novel Enhanced Protein Solution, in Knee Osteoarthritis Pain: a Randomised, Double-Blind Controlled Phase II/III Study. Abstract FRI0400]
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