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Bone Therapeutics’ first efficacy study of the JTA-004 viscosupplement to treat knee osteoarthritis showed that a single injection delivered higher pain reduction between baseline and six months post-treatment vs. a reference product (hylan G-F 20).
JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee osteoarthritis, which Bone Therapeutics has been developing in parallel with its core cell therapy pipeline. JTA-004 consists of hyaluronic acid, an analgesic and anti-inflammatory agent in an enriched protein solution.
The multicenter trial was prospective, randomized, double-blind and controlled. It included three JTA-004 strengths and one reference product, hylan G-F 20 (Synvisc). A total of 164 patients were randomly assigned to reference or one of the three JTA-004 groups. Results indicate that:
- At six months, patients in the three JTA-004 groups showed an improvement in pain vs. baseline ranging from 23.6 mm to 25.9 mm, while those in the reference group showed a 14.3 mm improvement.
- Due to high variability in primary endpoint at six months, statistically significant differences between the individual JTA-004 groups and the reference group were not achieved.
- All three JTA-004 strengths had a similar efficacy. Therefore, a post hoc exploratory analysis was performed between the reference group and all pooled JTA-004 treated patients. This analysis showed a 26.1 mm improvement for the pooled JTA-004 group vs. 15.6 mm for the reference group at six months, demonstrating a statistically significant superiority of the pooled JTA-004 group compared to hylan G-F 20.
Next steps in the commercialization of JTA-004 include future clinical development and dialogue with regulatory authorities.
Source: Bone Therapeutics
Bone Therapeutics’ first efficacy study of the JTA-004 viscosupplement to treat knee osteoarthritis showed that a single injection delivered higher pain reduction between baseline and six months post-treatment vs. a reference product (hylan G-F 20).
JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee...
Bone Therapeutics’ first efficacy study of the JTA-004 viscosupplement to treat knee osteoarthritis showed that a single injection delivered higher pain reduction between baseline and six months post-treatment vs. a reference product (hylan G-F 20).
JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee osteoarthritis, which Bone Therapeutics has been developing in parallel with its core cell therapy pipeline. JTA-004 consists of hyaluronic acid, an analgesic and anti-inflammatory agent in an enriched protein solution.
The multicenter trial was prospective, randomized, double-blind and controlled. It included three JTA-004 strengths and one reference product, hylan G-F 20 (Synvisc). A total of 164 patients were randomly assigned to reference or one of the three JTA-004 groups. Results indicate that:
- At six months, patients in the three JTA-004 groups showed an improvement in pain vs. baseline ranging from 23.6 mm to 25.9 mm, while those in the reference group showed a 14.3 mm improvement.
- Due to high variability in primary endpoint at six months, statistically significant differences between the individual JTA-004 groups and the reference group were not achieved.
- All three JTA-004 strengths had a similar efficacy. Therefore, a post hoc exploratory analysis was performed between the reference group and all pooled JTA-004 treated patients. This analysis showed a 26.1 mm improvement for the pooled JTA-004 group vs. 15.6 mm for the reference group at six months, demonstrating a statistically significant superiority of the pooled JTA-004 group compared to hylan G-F 20.
Next steps in the commercialization of JTA-004 include future clinical development and dialogue with regulatory authorities.
Source: Bone Therapeutics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
