All patients met primary endpoint
Optimized production process delivering critical improvements for future commercial use to be applied to all allogeneic platform clinical trials
BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces positive final results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB in 21 patients, supporting the future clinical development of the delayed union indication.
The Company also announces the development of an optimized production process for ALLOB, which the Company believes delivers critical improvements in consistency, scalability, cost-effectiveness and ease of use. In order to streamline the progress of ALLOB through late stage clinical trials and towards commercialization, Bone Therapeutics intends to implement this optimized manufacturing process for all future clinical development programmes, including the Phase IIB trial of ALLOB in delayed union fractures.
The Phase I/IIA study was a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study evaluated 21 patients, who each had a fracture that had failed to consolidate after a minimum of three and a maximum of seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (e.g. health status and pain).
At six months post administration, 100% of the 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 the clinical Global Disease Evaluation (GDE) score vs. baseline.
From a radiological perspective, the patients improved by on average 3.84 points on the TUS score (statistically significant), almost twice the required increase of two points. This minimum two-point increase was achieved by 16 out of 21 patients (76%).
From a clinical perspective, the health status of patients, as measured by the GDE score, improved statistically significantly by on average 48%. The minimum 25% improvement was achieved by 16 out of 21 patients (76%). Pain at the fracture site, an important secondary endpoint, was statistically significantly reduced by on average 61%.
Overall, ALLOB was shown to be well-tolerated and the safety profile was consistent with the interim analysis reported on 20 September 2017. As previously described in the literature covering clinical studies with allogeneic mesenchymal stem cells or their derivatives, it was observed that blood samples of about half of the patients contained donor-specific antibodies, either pre-existing or developed after administration.
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