Success criteria in phase III study of Biostat fibrin sealant not met


According to the 26-week results of a phase III study, announced by Spinal Restoration, Biostat Biologx fibrin sealant is not significantly more beneficial than saline injection for the treatment of single-level discogenic back pain. Spinal Restoration is currently determining the appropriate next steps for the Biostat system and the company.

The study was conducted at 20 centres in the USA and randomised 220 patients with single-level discogenic low back pain in a 3:1 ratio to injection of Biostat Biologx fibrin sealant or saline using the Biostat System. An additional 40 non-randomised patients received the fibrin sealant injections at two lumbar levels in a separate safety arm of the study. Ninety-six per cent of patients completed the 26-week visit and 50% of subjects had completed the final 78-week extended follow-up visit at the time of the analysis.

At 26 weeks, 33.5% of patients who received fibrin sealant met the pre-specified composite definition of patient success compared with 39.3% of patients in the saline control arm—therefore, the novel drug failed to meet the study’s success criteria. Clinically meaningful improvements in low back pain were achieved in 42.1% and 50% of fibrin sealant patients and control patients, respectively. Clinically meaningful improvements in the Roland-Morris Disability Questionnaire were achieved in 52.4% of the fibrin sealant patients and 50% of control patients. The outcomes reported in the patients treated at two lumbar levels were very similar to the results of the one level patients.

Gary Sabins, president and chief executive officer of Spinal Restoration, commented, “The outcomes of the phase III study are obviously very disappointing. We were very encouraged by the results obtained in our preclinical studies and pilot clinical trial and expected the phase III study to provide clear evidence of efficacy for the Biostat system. Many patients achieved significant, long-lasting improvements in their condition. Unfortunately, the benefits provided by injection of Biostat Biologx fibrin sealant with the Biostat system could not be distinguished from the benefits provided by injection of saline.”