BIOSENIC SA
Gosselies, Belgium, 22 December 2020, 7am CEST - BONE THERAPEUTICS
(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has completed recruitment and treated all patients in its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis. Topline results are anticipated on the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021. 'The Covid-19 pandemic has had a substantial impact on the progress of clinical studies globally. As a result, Bone Therapeutics successfully completing patient recruitment of this large clinical study, evaluating more than 700 patients, on time and schedule, is a tremendous achievement. The contribution of patients, clinicians, clinical study operators has been invaluable to achieving this major milestone. The efforts of our partner NBCD A/S has been crucial for the swift execution of the recruitment process in these very challenging conditions,' said Olivier Godeaux, Chief Medical Officer of Bone Therapeutics. 'Knee osteoarthritis remains a condition with a high unmet medical need affecting hundreds of millions of patients worldwide annually. A positive outcome for this pivotal study would provide these patients with a potential new valuable treatment option. Bone Therapeutics looks forward to reporting topline results in the third quarter of 2021.' The JTA-004 Phase III study is a controlled, randomized, double-blind trial. It is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee up to 12 months, compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study is being conducted in 22 centers across six European countries as well as Hong Kong. More than 700 patients have been treated. These patients fulfill all the strict protocol criteria including mild to moderate symptomatic knee osteoarthritis. 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. In a previous randomized, double-blind Phase II study involving 164 patients, JTA-004 showed superior clinical benefit with an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment.
(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has completed recruitment and treated all patients in its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis. Topline results are anticipated on the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021. 'The Covid-19 pandemic has had a substantial impact on the progress of clinical studies globally. As a result, Bone Therapeutics successfully completing patient recruitment of this large clinical study, evaluating more than 700 patients, on time and schedule, is a tremendous achievement. The contribution of patients, clinicians, clinical study operators has been invaluable to achieving this major milestone. The efforts of our partner NBCD A/S has been crucial for the swift execution of the recruitment process in these very challenging conditions,' said Olivier Godeaux, Chief Medical Officer of Bone Therapeutics. 'Knee osteoarthritis remains a condition with a high unmet medical need affecting hundreds of millions of patients worldwide annually. A positive outcome for this pivotal study would provide these patients with a potential new valuable treatment option. Bone Therapeutics looks forward to reporting topline results in the third quarter of 2021.' The JTA-004 Phase III study is a controlled, randomized, double-blind trial. It is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee up to 12 months, compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study is being conducted in 22 centers across six European countries as well as Hong Kong. More than 700 patients have been treated. These patients fulfill all the strict protocol criteria including mild to moderate symptomatic knee osteoarthritis. 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. In a previous randomized, double-blind Phase II study involving 164 patients, JTA-004 showed superior clinical benefit with an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment.
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Bone Therapeutics SA published this content on 22 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 December 2020 06:04:04 UTC
