Key Takeaways
- SB-01 Shows Consistent Safety Across Studies: Despite missing the primary endpoint, SB-01 maintained a strong safety and durability profile in both Phase II and Phase III trials.
- Sham Response Impacts Statistical Significance: An unexpectedly high and variable sham control response across sites influenced the trial’s ability to demonstrate statistical superiority.
- Unmet Need in Degenerative Disc Disease (DDD) Remains: Up to 30% of patients with cervical DDD and 20% with lumbar DDD do not respond to nonsurgical treatments, underscoring the demand for novel therapies.
Results from the Phase III MODEL trial (NCT05516992) showed that Spine BioPharma’s SB-01 (vicatertide), a TGF-β antagonist delivered via intradiscal injection for chronic low back pain (CLBP) associated with degenerative disc disease (DDD), failed to meet its primary endpoint. However, the company stated that the treatment maintained a robust and durable safety and efficacy profile consistent with prior studies.1
What did the Trial Results Reveal About the Clinical Potential of SB-01?
“The SB-01 patients responded as anticipated and consistent with the Phase II study,” said Fran Magee, DVM, CTO, in a press release. “In contrast, the sham control response was statistically significantly higher than observed in the Phase II study. The statistical design of this Phase III study anticipated a high sham control success, as observed in the Phase II study and typically seen in CLBP studies. We are surprised by the very high sham control response in this study that kept us from achieving statistical significance.”
Key Findings from the MODEL Trial
- The multicenter, randomized, double-blind, placebo-controlled MODEL trial evaluated the safety and efficacy of SB-01 in 417 patients.
- Patients were randomly assigned to receive either SB-01 via intradiscal injection or a sham needle placement for each treated disc.
- The primary endpoint of the trial was composite success in pain intensity and function using the Oswestry Disability Index and Numerical Rating Scale (ODI+NRS) at six months compared to sham.
- The secondary endpoint was change from baseline in pain on the NRS at six months.2
- While the trial did not achieve composite success in pain intensity and function based on ODI+NRS, 67% of patients in the SB-01 group achieved this benchmark, with 62% maintaining benefit at 12 months.
- Secondary outcomes also showed clinically meaningful improvements, with a 75% ODI response rate at six months and 71% at twelve months, though these did not reach statistical significance.
- Notably, an unexpectedly high and variable sham response across sites impacted the trial’s ability to demonstrate statistical superiority.1
Challenges in Pain Trials
“This was a landmark, well-designed clinical trial with strict enrollment criteria and very high follow-up rates,” said Christopher Gilligan, MD, principal investigator of the MODEL trial, in the press release. “The study employed a rigorous composite endpoint requiring patients to achieve both clinically meaningful improvement in both pain intensity and pain-related function. Pain studies are challenging and are susceptible to a sham control response, which was particularly high in this study. We are thankful to the patients, their families, investigators, clinical coordinators, and research associates who participated in this clinical trial for CLBP.”
Ongoing Need for Alternative DDD Treatments
According to a study published in The National Center for Biotechnology Information, an estimated 40% of individuals aged 40 years and older are affected by DDD globally. By 80 years of age, the prevalence increases to 80%.
While nonsurgical treatments can help manage pain and disability from degenerative disc disease, up to 30% of patients with cervical DDD and anywhere from 10% to 20% of patients with lumbar DDD may not respond to these approaches.3
What’s Next for SB-01?
“Despite our disappointment in missing the primary endpoint, we are quite proud of enrolling and completing this trial under strict FDA guidelines,” said Marc Viscogliosi, CEO, Spine BioPharma, in the press release. “We ran a solid trial and had we achieved our anticipated sham control group response, the results would have been statistically significant in favor of SB-01.”
References
- Spine BioPharma Announces Topline Results from Phase 3 MODEL Trial For SB-01 (vicatertide) In Chronic Low Back Pain Associated with Degenerative Disc Disease. BusinessWire. August 1, 2025. Accessed August 4, 2025. https://www.businesswire.com/news/home/20250801165954/en/Spine-BioPharma-Announces-Topline-Results-from-Phase-3-MODEL-Trial-For-SB-01-vicatertide-In-Chronic-Low-Back-Pain-Associated-with-Degenerative-Disc-Disease
- Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (MODEL). Clinicaltrials.gov. August 1, 2025. Accessed August 4, 2025. https://clinicaltrials.gov/study/NCT05516992?term=SB-01%20MODEL&rank=1
- Artificial discs for lumbar and cervical degenerative disc disease -update: an evidence-based analysis. NIH. Accessed August 4, 2025. https://pubmed.ncbi.nlm.nih.gov/23074480/#:~:text=Clinical%20need:%20Degenerative%20disc%20disease%20is%20the,among%20those%20aged%2080%20years%20or%20older.
