High-level results are expected in Q3 2021
Gosselies, Belgium, 22 December 2020, 7m CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company that treats unmet medical needs in orthopedics and other diseases, today announced it has terminated recruitment and treatment all patients in the Phase III critical clinical study with the enhanced viscosupplement, JTA-004, in patients with knee osteoarthritis. High yields are expected on the 3-month endpoint and the 6-month follow-up period in the third quarter of 2021.
“Covid-19 pandemic disease has had a significant impact on the progress of clinical studies worldwide. As a result, Bone Therapeutics successfully completes patient recruitment of this large clinical study, evaluating more than 700 patients, by time and schedule, an outstanding achievement. The contribution of patients, clinicians, clinical study operators has been extremely helpful in achieving this major milestone. The efforts of our NBCD A / S partner have been critical to the speedy implementation of the recruitment process in these challenging circumstances,” said Olivier Godeaux, Chief Medical Officer of Bone Therapy. “Knee osteoarthritis remains a condition of high unmet medical need affecting hundreds of millions of patients worldwide each year. A positive outcome for this important study would provide a valuable new treatment option for these patients. Bone Therapeutics looks forward to reporting high-quality results in the third quarter of 2021. ”
Phase III study JTA-004 is a randomized, double-blind controlled trial. It evaluates the ability of a single intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee by up to 12 months, compared to placebo or Hylan GF 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 were treated. These patients meet the strict protocol criteria including moderate to moderate knee osteoarthritis.
JTA-004 is the next generation of Bone Therapeutics of intra-articular injectable for the treatment of osteoarthritic pain in the knee. It contains a special blend of hyaluronic acid – a natural component of knee synovial fluid, plasma proteins, and a fast-acting analgesic. JTA-004 is intended to provide additional lubrication and protection to the cartilage of the arthritic component and to relieve osteoarthritic pain. In a previous randomized Phase II study, blinded in 164 patients, JTA-004 showed better clinical benefit with better pain relief at 3 and 6 months compared to Hylan GF 20, a global market leader in the treatment of osteoarthritis.
About bone therapy
Bone Therapeutics is a leading biotechnology company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a mixed package of cellular and biological therapies at various levels from preclinical programs in immunomodulation to mid-end clinical development for orthopedic conditions, targeting markets with high medical needs without performance and innovation limited.
Osteoarthritis (OA), also known as degenerative joint disease, is the most common degenerative joint condition in which the protective cartilage in the joints gradually breaks down resulting in joint pain, swelling, stiffness and poor range of motion. The knee is one of the joints most affected by osteoarthritis, with an estimated 250 million cases worldwide.
Bone Therapeutics is developing an improved next-generation viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Featuring a unique blend of plasma proteins, hyaluronic acid – a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 is intended to provide additional lubrication and protection to the cartilage of the arthritic component and reduction of osteoarthritic pain and inflammation. Results of positive Phase IIb efficacy in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared with primary viscosupplement.
Bone Therapeutics cell treatment products are manufactured to the highest GMP standards and are protected by an extensive IP package (Intellectual Property) covering ten patent families as well as experience. The company is based in BioPark in Gosselies, Belgium. Further information is available at www.bonetherapeutics.com.
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