Spine BioPharma Reveals Key Findings from Stage 3 MODEL Test for SB-01 (vicatertide) in Persistent Lower Back Pain due to Degenerative Disc Disease

Spine BioPharma Reveals Key Findings from Stage 3 MODEL Test for SB-01 (vicatertide) in Persistent Lower Back Pain due to Degenerative Disc Disease

In a recent Phase 3 clinical trial, Spine BioPharma's lead candidate, SB-01 For Injection, a first-in-class treatment for Degenerative Disc Disease (DDD), did not meet its primary endpoint at Month 6. The trial, known as the MODEL trial, was a U.S. multi-center, randomized, double-blind, placebo-controlled study.

The trial enrolled 417 patients, with the SB-01 group showing clinically meaningful improvements in pain and function. At Month 6, 67% of SB-01 patients reached the composite success criteria (pain intensity and pain-related function), a figure consistent with prior Phase 2 findings.

However, the sham control group response was higher than anticipated, particularly at some trial sites, which reduced the ability to demonstrate a statistically significant treatment effect. This high sham effect prevented SB-01 from achieving statistical significance despite the clinically meaningful improvements and a robust safety profile consistent with earlier trials.

SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity. TGF-Beta is a pleiotropic cytokine that can lead to negative downstream effects such as inflammation, fibrosis, neoinnervation, hyperexcitability of nerves, and cell proliferation when present in high concentrations. By modulating TGF-Beta concentration, SB-01 mitigates these negative effects.

A subset analysis of sites with sham response rates consistent with earlier data showed a more favorable treatment difference, suggesting site variability influenced outcomes. Spine BioPharma plans further data analysis and discussions with the FDA to explore approval pathways, combining Phase 1 and 2 data with these results.

Patients were followed at Week 2, Week 6, Month 3, Month 6, and Month 12. They were evaluated for pain intensity utilizing the Numerical Rating Scale (NRS) and pain-related function using the Oswestry Disability Index (ODI). SB-01 patients saw a numerical and clinically meaningful improvement in pain intensity and pain-related function.

Despite the trial's primary endpoint not being met, Spine BioPharma remains 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 and their ongoing work, visit www.spinebiopharma.com.

For corporate inquiries, contact Marc Viscogliosi, Chief Executive Officer, at 212-583-9700 or [email protected].

[1] Reference for Phase 2 findings [2] Reference for Phase 3 trial results and future plans [3] Reference for earlier Phase findings consistent with Phase 3 results [5] Reference for safety profile consistency with earlier trials

1. The trial's results, though not meeting the primary endpoint at Month 6, showcased clinically meaningful improvements in pain and function for SB-01 patients, with 67% reaching composite success criteria.
2. The high sham response rates, particularly at some trial sites, reduced the ability to demonstrate a statistically significant treatment effect for SB-01, despite its robust safety profile consistent with earlier trials.
3. A subset analysis of sites with sham response rates consistent with earlier data showed a more favorable treatment difference, suggesting site variability may have influenced outcomes.
4. Spine BioPharma plans further data analysis and discussions with the FDA to explore approval pathways, combining Phase 1, 2, and 3 data with these results.
5. SB-01, a 7-amino acid synthetic peptide, binds to and antagonizes TGF-Beta activity, mitigating negative effects like inflammation, fibrosis, neoinnervation, nerve hyperexcitability, and cell proliferation when present in high concentrations, potentially impacting chronic diseases, medical conditions, respiratory conditions, cardiovascular health, fitness and exercise, health and wellness, and even cancer.

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