Spine BioPharma Initiates Phase 3 Trial for First-in-Class Intradiscal Treatment of Chronic Low Back Pain
Key Insights
Spine BioPharma (search) has treated the first patient in its Phase 3 MODEL study of SB-01, marking the first intradiscal pharmacologic treatment to reach Phase 3 for degenerative disc disease-related pain.
The 400-patient study across 30 US sites evaluates SB-01, a 7-amino acid peptide that antagonizes TGF-β1 (search) activity to reduce inflammation and potentially restore disc structural integrity.
With 22.5 million Americans diagnosed with chronic low back pain from degenerative disc disease annually, SB-01 offers a potential non-opioid, non-surgical alternative requiring only a single injection.
Spine BioPharma (search) has achieved a significant milestone in the treatment of chronic low back pain by dosing the first patient in its Phase 3 clinical study of SB-01 For Injection. The trial, known as the MODEL Study (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), represents the first intradiscal pharmacologic treatment to enter Phase 3 studies for pain-related disability associated with degenerative disc disease (DDD).
The first patient was treated at Conquest Research (search) in Winter Park, Florida, under the supervision of Principal Investigator Dr. Malisa Agard. The Phase 3 study will enroll up to 400 patients across 30 investigational sites throughout the United States.
Addressing a Massive Unmet Medical Need
Approximately 22.5 million Americans are diagnosed with chronic low back pain from degenerative disc disease annually, according to Ravindra 2018 data cited by the company. Globally, 266 million individuals experience DDD and its associated chronic low back pain each year. Despite this significant burden, patients have limited effective treatment options.
"CLBP is the second most common reason for chronic opioid use," the company notes, referencing Hudson 2008 data, highlighting the addiction risks and serious side effects associated with current pain management approaches. After years of palliative treatments including physical therapy, NSAIDs, epidural steroid injections, and nerve blocks, patients often face surgery as their only remaining option, which comes with high costs, lengthy recovery periods, and unpredictable outcomes.
Novel Mechanism of Action
SB-01 is a 7-amino acid peptide designed to bind to and antagonize transforming growth factor beta 1 (TGF-β1 (search)) activity. TGF-β1 is an inflammatory cytokine that is often highly expressed in degenerated discs, according to Peng 2006 research. High TGF-β1 levels within diseased discs are associated with inflammation, pain mediation, and degradation of extracellular matrix, causing discs to lose structural integrity.
The treatment consists of a single intradiscal injection directly into the diseased disc. By antagonizing TGF-β1 (search) overexpression, SB-01 aims to decrease inflammation and pain mediation while promoting extracellular matrix production, potentially improving the structural integrity of the diseased disc, as demonstrated in Kwon 2013 studies.
"TGF-β1 (search) also stimulates the expression of nerve growth factor, leading to an increase in sensory neurons and discogenic pain," the company explains. "SB-01 treatment of a diseased disc antagonizes the overexpression of TGF-β1, which decreases inflammation and supports the production of extracellular matrix, maintaining the structural integrity of the disc, decreasing pain and improving pain related disability."
Clinical Development and Financing
The advancement to Phase 3 follows the company's completion of a $13 million Series B equity financing in March 2022. Existing investors including Viscogliosi Bros. (search), LLC, Cercano Management, and Pacira Biosciences (search) participated in the financing round to support further development of the first-in-class therapeutic.
"We are delighted to continue to benefit from the financial support and expertise of our distinguished investor-partners," said Spine BioPharma (search) CEO Marc Viscogliosi. "This Series B financing speaks to their confidence in our company, and it will help drive the research and development of SB-01, a unique therapeutic that offers a potential non-opiate, non-surgical treatment option to chronic low back pain patients."
Potential to Transform Treatment Paradigm
SB-01 offers the potential for a single intradiscal injection to provide patients with six months of clinically meaningful symptomatic relief. This represents a significant departure from current treatment approaches that focus on pain management rather than addressing the underlying pathophysiology of disc degeneration.
"Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved disease-modifying agent, a therapy that could relieve pain and increase function with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care," the company states.
The Phase 3 MODEL study will evaluate whether this first-in-class intradiscal approach can deliver on its promise to provide a non-opioid, non-surgical treatment option for the millions of patients suffering from chronic low back pain due to degenerative disc disease.