Chronic Low Back Pain linked to Degenerative Disc Disease treated with SB-01 (vicatertide) in Phase 3 MODEL clinical trial findings announced by Spine BioPharma

Chronic Low Back Pain linked to Degenerative Disc Disease treated with SB-01 (vicatertide) in Phase 3 MODEL clinical trial findings announced by Spine BioPharma

In a recent development, Spine BioPharma's Phase 3 MODEL trial for its lead candidate, SB-01 (vicatertide), a TGF-β antagonist for intradiscal treatment of Chronic Low Back Pain (CLBP) associated with Degenerative Disc Disease (DDD), has reported its topline results.

SB-01, a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity, was tested in the trial. The drug, which modulates TGF-Beta concentration without eliminating it, aims to mitigate the negative downstream effects of this pleiotropic cytokine.

However, the trial did not meet its primary endpoint of pain intensity and pain-related function improvement at 6 months compared to a sham control. Despite this, SB-01 showed a robust safety profile consistent with prior studies and demonstrated numerical and clinically meaningful improvements in pain and function.

Notably, in sites with expected sham response rates, SB-01 nearly achieved statistical significance (p=0.051) for the composite primary endpoint (ODI+NRS). In the same patient subset, SB-01 also outperformed the sham control for the secondary endpoint of ODI response (p=0.040).

The trial, a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 study, enrolled 417 patients across 30 sites in the United States. Each patient received a single 1.5 ml intradiscal injection of SB-01 or a sham control.

The trial followed patients at Week 2, Week 6, Month 3, Month 6, and Month 12, evaluating pain intensity using the Numerical Rating Scale (NRS) and pain-related function using the Oswestry Disability Index (ODI). In the Intent-to-Treat (ITT) analysis, the SB-01 group achieved a 67% success rate (ODI+NRS) at Month 6, but this was not statistically significant compared to the sham control group.

The CEO of Spine BioPharma expressed disappointment in missing the primary endpoint, but pride in completing the trial under strict FDA guidelines. The principal investigator of the trial praised its design and high follow-up rates, but noted the challenge of pain studies and the high sham control response in this study.

Spine BioPharma is committed to developing non-opiate, non-surgical treatments that will reduce pain, restore function, and slow or stop pathological disease progression. For more information about Spine BioPharma, visit www.spinebiopharma.com.

The press release for this news was issued by Business Wire. For corporate inquiries, please refer to the Contacts section of the article.

[1] Spine BioPharma Press Release [2] ClinicalTrials.gov [3] ScienceDirect

1. In light of the trial's results, Spine BioPharma might consider expanding its research to investigate the potential benefits of SB-01 in managing chronic medical conditions, such as chronic kidney disease or other chronic diseases.
2. The robust safety profile of SB-01, in combination with its clinically meaningful improvements in pain and function, could contribute to the field of health and wellness by providing a new treatment option for individuals suffering from various painful conditions.
3. The intriguing results of the SB-01 trial, especially in sites with expected sham response rates, could spark further interest in the scientific community, leading to new research on the role of TGF-Beta in various conditions, including degenerative disc disease, and potentially in the development of novel treatment strategies.

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