Press Release
First patients treated following resumption of clinical activities in
JTA-004 phase III study approved in five of seven territories
Gosselies,
The JTA-004 phase III study is a controlled, randomized, double-blind trial. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading current osteoarthritis treatment on the market. In the study, 676 patients with mild to moderate symptomatic knee osteoarthritis are expected to be enrolled. The study will be conducted in approximately 20 centers in six European countries as well as Hong Kong SAR.
“The resumption of the JTA-004 phase III study with the start of patient recruitment is a very important development for patients suffering from the chronic and underserved condition of knee osteoarthritic pain and seeking novel treatments that could be provided by our enriched protein solution,” said
“I’m very proud of all our teams for their efforts to reinitiate this crucial JTA-004 phase III study while we are still recovering from a global pandemic,” said
Reporting of the topline results of the study on the 3-month primary endpoint and 6-month follow-up period is planned in the second half of 2021.
JTA-004 is Bone Therapeutics’ next generation of intra-articular injectables for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, 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 phase II study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment.
About Knee Osteoarthritis
Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250 million cases worldwide.
The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.
About
Bone Therapeutics’ other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by regulatory authorities in
The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy, maxillofacial and dental applications.
Bone Therapeutics’ cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies,
For further information, please contact:
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com
International Media Enquiries:
Tel: 44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor Enquiries:
NewCap Investor Relations
Pierre Laurent,
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu
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