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Vicatertide (SB-01) is a first-in-class synthetic 7-amino acid peptide biologic developed by Spine BioPharma for the treatment of chronic low back pain associated with lumbar degenerative disc disease (DDD). It functions as a transforming growth factor beta (TGF-β) antagonist, specifically designed to bind to and block TGF-β activity within the intervertebral disc. By inhibiting TGF-β, which is implicated in the inflammatory and degenerative processes of the disc, vicatertide aims to reduce pain, restore function, and potentially slow or stop disease progression. The drug is administered via a single intradiscal injection directly into the affected spinal discs. In 2025, Spine BioPharma reported results from the Phase 3 MODEL trial, which demonstrated durable improvements in pain and function at one year, although the trial did not meet its primary statistical endpoint due to an unexpectedly high placebo response.
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