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Spine BioPharma completed enrollment of its U.S. Phase III clinical trial of SB-01 For Injection (SB-01).
The multi-center, randomized, double-blind, placebo-controlled MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pharmacologic treatment to enter Phase III studies for the treatment of chronic low back pain and its associated pain-related loss of function caused by degenerative disc disease.
“This is an important milestone for the patient and physician community, and for the Company. After years of conservative treatment, DDD patients have no alternative but to ultimately undergo surgery at a high dollar cost, with long recovery periods and unpredictable outcomes,” said Marc Viscogliosi, CEO of Spine BioPharma. “We are extremely pleased to have completed enrollment of the SB-01 MODEL trial ahead of schedule. This accomplishment brings SB-01 one step closer to addressing the unmet need of millions of patients who suffer from CLBP associated with DDD.”
SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects.
Source: Spine BioPharma
Spine BioPharma completed enrollment of its U.S. Phase III clinical trial of SB-01 For Injection (SB-01).
The multi-center, randomized, double-blind, placebo-controlled MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year...
Spine BioPharma completed enrollment of its U.S. Phase III clinical trial of SB-01 For Injection (SB-01).
The multi-center, randomized, double-blind, placebo-controlled MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pharmacologic treatment to enter Phase III studies for the treatment of chronic low back pain and its associated pain-related loss of function caused by degenerative disc disease.
“This is an important milestone for the patient and physician community, and for the Company. After years of conservative treatment, DDD patients have no alternative but to ultimately undergo surgery at a high dollar cost, with long recovery periods and unpredictable outcomes,” said Marc Viscogliosi, CEO of Spine BioPharma. “We are extremely pleased to have completed enrollment of the SB-01 MODEL trial ahead of schedule. This accomplishment brings SB-01 one step closer to addressing the unmet need of millions of patients who suffer from CLBP associated with DDD.”
SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects.
Source: Spine BioPharma
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
