BELGIUM – Bone therapeutics, a cell therapy company that focuses on orthopedic treatment, has signed a loan agreement worth €16m with European Investment Bank (EIB) to bolster its ongoing development and innovation of orthopedic treatment.
The EIB loan financing will be disbursed in two tranches of €8 million each, subject to conditions precedent.
It will used to support and prepare Bone Therapeutics’ lead asset, the enhanced visco supplement JTA-004 for future regulatory approval and commercialization.
JTA-004, is being evaluated in a registrational phase III clinical trial for the treatment of osteoarthritic pain in the knee.
This is the most prevalent knee condition affecting an estimated 250 million patients world-wide with topline results of this study expected in the third quarter of 2021.
Following a positive outcome of the study, Bone Therapeutics plans to submit a marketing authorization application to European regulatory authorities in the first half of 2022.
Bone Therapeutics continues to engage with potential partners to develop and commercialize JTA-004 in Europe, US and Asia.
Additionally, the EIB financing will also be used to accelerate the clinical development and trials of ALLOB, Bone Therapeutics’ scalable allogeneic cell therapy platform.
ALLOB therapy recently got back its results from the phase i/iia study trial that was conducted for six months to evaluate its safety and efficacy in treatment of delayed union fracture of long bones.
The study was conducted on 21 patients with fractures that failed to consolidate between three and seven months.
Results published from the study confirmed that ALLOB was generally well-tolerated and that all patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of patients’ health status as measured by the clinical Global Disease Evaluation (GDE) score vs. baseline at six months post administration.
ALLOB is also currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk fractures in the shinbone (tibia).
This study will assess and compare against placebo the potential for ALLOB to accelerate fracture healing and prevent late-stage complications in these patients, in association with standard of care stabilization surgery after a follow-up period of 6 months.
Following the approval in seven European countries, the study is now in the process of enrolling 178 patients in over 40 sites and anticipates to finalize patient recruitment in first half of 2022.