Spine BioPharma has concluded enrollment in its Phase 3 MODEL clinical trial, evaluating SB-01 For Injection for the treatment of chronic low back pain (CLBP) caused by degenerative disc disease (DDD). The multi-center, double-blind, randomized, placebo-controlled trial enrolled 417 subjects across 30 investigational sites in the U.S. over two years. This study aims to assess the safety and efficacy of SB-01 in adult patients experiencing CLBP and related functional impairments due to lumbar DDD, a condition affecting millions worldwide. The successful completion of enrollment ahead of schedule represents a significant milestone in the development of a non-surgical alternative for patients with DDD.
SB-01: A Novel Approach to CLBP Treatment
SB-01 is a synthetic 7-amino acid peptide designed to bind to and antagonize TGF-Beta activity. TGF-Beta, a cytokine present in nearly every tissue and cell type, plays a role in various diseases, where elevated levels can lead to inflammation, fibrosis, nerve hyperexcitability, and cell proliferation. SB-01 modulates TGF-Beta levels without fully depleting them, aiming to reduce the adverse downstream effects. This mechanism of action distinguishes SB-01 as a potential first-in-class intradiscal pharmacologic treatment for CLBP and associated functional deficits linked to DDD.
The Phase 3 MODEL Trial Design
The MODEL trial is designed to evaluate the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and associated impairment in pain-related function due to lumbar DDD. The trial's primary endpoints include assessing pain relief and functional improvement compared to placebo. Secondary endpoints may include measures of disability, quality of life, and reduction in opioid use. The double-blind, placebo-controlled design ensures an objective evaluation of SB-01's therapeutic potential.
Addressing an Unmet Medical Need
Approximately 266 million individuals worldwide experience DDD, with 22.5 million Americans diagnosed each year. Current treatment approaches primarily focus on managing symptoms through physical therapy, chiropractic care, NSAIDs, or prescription opioids. More invasive interventions, such as epidural steroid injections, nerve blocks, radiofrequency ablation, or surgery, are considered for patients with chronic moderate-to-severe DDD. However, these options often yield unpredictable benefits and carry significant risks. According to Spine BioPharma, SB-01 offers a potential alternative by targeting the underlying pathology of DDD, rather than merely alleviating symptoms.
Management Perspective
"This is an important milestone for the patient and physician community, and for the company," said Marc Viscogliosi, CEO of Spine BioPharma. "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 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."
