BONE THERAPEUTICS, the cell therapy company addressing high unmet medical needs in orthopedics and bone diseases, today announces it has been granted EUR 1.0 million in non-dilutive funding from the Directorate-General for Economy, Employment and Research of the Walloon Region, Belgium. This funding will provide further financial support to Bone Therapeutics, in addition to recent financing, to advance its current pivotal phase III clinical study with the enriched protein solution, JTA-004.
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 compared to placebo or Hylan G-F 20, the leading current osteoarthritis treatment on the market. The study is being conducted in six European countries as well as Hong Kong SAR. Since the initiation of the trial in mid-May 2020, 164 patients have already been treated, roughly 20% of the targeted assessable patients. At the current recruitment rate, Bone Therapeutics expects to complete patient enrolment before year-end and anticipates reporting topline results on the 3-month primary endpoint and 6-month follow-up period in the second half of 2021.
"The continued support of Bone Therapeutics by the Directorate-General for the Economy, Employment and Research of the Walloon Region, and especially the Department SPW-Research, has been very important to advancing our program of orthopedics and bone disease therapies,” said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. “This specific financial support will provide additional assistance in further advancing our phase III trial in knee osteoarthritis and will add extra momentum to discussions with potential business partners. The successful completion of this study aims at confirming the safety and efficacy of JTA-004 towards commercialization as a potential new and much-needed treatment option for this large patient population."
The non-dilutive funding is granted under the form of ‘avances récupérables’ to support specific research and development programs and is subject to suspensive conditions. Under the applicable conditions, the funding is reimbursable over the economic life of the project (25 years). Thirty per cent is refundable based on a fixed reimbursement schedule, while the balance is refunded under the form of royalties over the same period.