Spine BioPharma's Phase 3 Back Pain Drug Fails to Meet Primary Endpoint, Attributes Miss to High Sham Response

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Spine BioPharma's lead drug candidate, SB-01 (vicatertide), did not achieve its primary endpoint in a Phase 3 trial for chronic low back pain associated with degenerative disc disease35.

The company attributed the failure to an unexpectedly high response rate in the placebo (sham) arm of the study3.

The MODEL Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled study targeting adults with chronic low back pain due to degenerative disc disease; it enrolled 417 participants across 30 U.S. sites1.

SB-01 is a synthetic peptide designed to antagonize TGF-Beta activity, potentially modulating inflammation and fibrosis without fully depleting TGF-Beta1.

This is the first intradiscal pharmacologic treatment for CLBP from degenerative disc disease to reach Phase 3 clinical trials1.

Sources:

1. https://www.clinicaltrialsarena.com/news/spine-biopharma-back-pain-trial/

3. https://firstwordpharma.com/story/5985711

5. https://www.biospace.com/press-releases/spine-biopharma-announces-topline-results-from-phase-3-model-trial-for-sb-01-vicatertide-in-chronic-low-back-pain-associated-with-degenerative-disc-disease