Bone Therapeutics reported positive interim efficacy results for its Phase I/IIA delayed-union study evaluating ALLOB in 16 patients. The Data and Safety Monitoring Board recommends ending the trial early due the positive data. Due to the DSMB recommendation, Bone Therapeutics has stopped recruitment and is planning for the next stage of the study.
ALLOB is the company's allogeneic bone cell therapy product. This six-month, open-label trial tested ALLOB in treating delayed-union long bones fractures. The 16 patients, who suffered fractures that didn't consolidate over a three-to-seven month period, received percutaneous administration of ALLOB into their fracture site.
Researchers evaluated fracture healing with clinical and radiological criteria.
Here are four takeaways:
1. All patients fulfilled the study's primary endpoint at six-month follow up, indicating all increased at least two points on the radiological Tomographic Union Score or improved at least 25 percent on the clinical Global Disease Evaluation score.
2. Overall, researchers saw a four-point average improvement on the TUS score. Thirteen patients achieved the minimum two-point increase.
3. Patients' health status improved by an average of 48 percent within the GDE score. Twelve patients achieved the minimum 25 percent improvement.
4. The study found patients tolerated ALLOB well, overall.
The company recently reported positive results evaluating ALLOB for lumbar spinal fusion.