Spine BioPharma, Inc. announced that its Phase 3 MODEL trial evaluating SB-01 for the treatment of chronic low back pain (CLBP) associated with degenerative disc disease (DDD) did not meet its primary endpoint. The MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) was designed to assess pain intensity and pain-related function at six months post-treatment compared to sham control.
The trial enrolled 417 patients with 1- or 2-level DDD across 30 sites in the United States. Participants were randomized 1:1 to receive a single 1.5 ml intradiscal injection of SB-01 or a sham control. Patients were monitored at Week 2, Week 6, Month 3, and Month 6, with an additional follow-up at Month 12. The primary endpoint was a composite of pain reduction and improved function, requiring a 2-point decrease on the Numerical Rating Scale (NRS) and a 15-point improvement on the Oswestry Disability Index (ODI).
While SB-01 showed a clinically meaningful improvement in both pain intensity and pain-related function, the trial did not achieve statistical significance compared to the sham control. The SB-01 response was consistent across all measured timepoints up to Month 6 and remained durable through Month 12. According to the Intent-to-Treat (ITT) analysis, 67% of patients in the SB-01 group met the composite primary endpoint at Month 6, and 62% at Month 12.
A secondary endpoint analysis using the ODI alone showed a success rate of 75% at Month 6 and 71% at Month 12 in the SB-01 group. However, these results were also not statistically significant when compared to the sham control group. No difference in treatment response was observed between patients with 1- or 2-level DDD.
SB-01 demonstrated a robust safety profile consistent with findings from the prior Phase 2 study involving 325 patients. This safety profile was maintained throughout the Phase 3 trial.
The sham control group exhibited higher-than-expected success rates at several investigational sites. This inconsistent sham control response was identified as a key factor that affected the statistical outcome of the trial. At sites where the sham control response aligned with expectations from the Phase 2 study, SB-01 showed a stronger relative performance.
A subset analysis was conducted on 227 patients from sites with an anticipated sham response rate. In this subgroup, 70% of SB-01 patients met the composite primary endpoint, compared to 59% of the sham group, with a nominal p-value of 0.051. For the ODI alone, the success rates were 79% in the SB-01 group and 69% in the sham group, with a nominal p-value of 0.040.
Fran Magee, Chief Technology Officer at Spine BioPharma, stated, “The SB-01 patients responded as anticipated and consistent with the Phase 2 study. In contrast, the sham control response was statistically significantly higher than observed in the Phase 2 study.”
Chief Executive Officer Marc Viscogliosi noted that while the trial did not meet the primary endpoint, it was conducted under strict FDA guidelines. Principal Investigator Christopher Gilligan described the trial as a well-designed study with strict enrollment criteria and high follow-up rates, and noted that high sham control responses are a known challenge in CLBP studies.
Spine BioPharma will complete its analysis of the trial data and plans to meet with the FDA to discuss the results from this trial, along with data from previous Phase 1 and 2 studies to explore potential regulatory pathways for SB-01.
