Spine BioPharma has concluded subject enrolment in its Phase III MODEL clinical trial of SB-01 For Injection, aimed at treating chronic low back pain (CLBP) caused by degenerative disc disease (DDD).
The trial enrolled a total of 417 subjects across 30 investigational sites in the US over a period of two years.
This multicentre, double-blind, randomised, placebo-controlled trial is designed to evaluate the safety and efficacy of SB-01 in adults experiencing CLBP and related functional impairments due to lumbar DDD.
SB-01 is claimed to be the first intradiscal pharmacologic treatment to enter Phase III trials for CLBP management and associated functional deficits linked to DDD.
A synthetic peptide, it attaches to and antagonises TGF-Beta activity.
TGF-Beta is a cytokine found in nearly every tissue and cell type and is stored in large quantities in the extracellular matrix. It also has suppressive and stimulatory signalling pathways.
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By GlobalDataIn various diseases, elevated TGF-Beta levels can result in negative outcomes, such as inflammation, fibrosis, nerve hyperexcitability, and cell proliferation.
SB-01 works by modulating TGF-Beta levels, without fully depleting them, to reduce the adverse downstream effects.
Spine BioPharma CEO Marc Viscogliosi said: “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.
“We are extremely pleased to have completed enrolment 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.”
