The first patient has been treated in a U.S. Phase III clinical study of Spine BioPharma’s SB-01 For Injection. The SB-01 Phase III study is known as MODEL (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine). SB-01 is said to be the first intradiscal pharmacologic treatment to enter Phase III studies for the treatment of pain-related disability, associated with degenerative disc disease.
The study is being conducted at 30 investigational sites across the U.S., enrolling up to 400 patients.
SB-01 is a 7-amino acid peptide that binds to and antagonizes TGFβ1 activity. TGFβ1 is an inflammatory cytokine that is often highly expressed in degenerated discs. High TGFβ1 levels within a diseased disc are associated with inflammation, pain mediation and the degradation of the extracellular matrix, causing the disc to lose structural integrity. SB-01 treatment consists of a single intradiscal injection in the diseased disc and antagonizes the overexpression of TGFβ1.
The first patient has been treated in a U.S. Phase III clinical study of Spine BioPharma's SB-01 For Injection. The SB-01 Phase III study is known as MODEL (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine). SB-01 is said to be the first intradiscal pharmacologic treatment to enter Phase III studies for the treatment of...
The first patient has been treated in a U.S. Phase III clinical study of Spine BioPharma’s SB-01 For Injection. The SB-01 Phase III study is known as MODEL (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine). SB-01 is said to be the first intradiscal pharmacologic treatment to enter Phase III studies for the treatment of pain-related disability, associated with degenerative disc disease.
The study is being conducted at 30 investigational sites across the U.S., enrolling up to 400 patients.
SB-01 is a 7-amino acid peptide that binds to and antagonizes TGFβ1 activity. TGFβ1 is an inflammatory cytokine that is often highly expressed in degenerated discs. High TGFβ1 levels within a diseased disc are associated with inflammation, pain mediation and the degradation of the extracellular matrix, causing the disc to lose structural integrity. SB-01 treatment consists of a single intradiscal injection in the diseased disc and antagonizes the overexpression of TGFβ1.
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