Spine BioPharma is a biopharmaceutical company focused on developing non-opiate, non-surgical therapies for the treatment of chronic low back pain and related disability caused by degenerative disc disease (DDD). Its lead candidate, SB-01 For Injection, is a first-in-class therapeutic for DDD. SB-01 is a 7-amino acid peptide that binds to and antagonizes transforming growth factor beta one (TGF𝛽1) activity, an inflammatory cytokine often highly expressed in degenerated discs. By decreasing inflammation, pain mediation, and supporting extracellular matrix production, SB-01 aims to maintain the structural integrity of diseased discs, relieve pain, and restore function.
In March 2022, Spine BioPharma completed a USD 13 million Series B financing round to support the clinical advancement of SB-01. The company initiated a Phase 3 clinical study, known as the MODEL Study, in September 2022 after receiving FDA approval. This landmark study evaluates the efficacy of a single intradiscal injection of SB-01 in providing six months of clinically meaningful symptomatic relief for CLBP-DDD patients. The MODEL Study is enrolling up to 400 patients across 30 investigational sites in the US.
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