Spine BioPharma Initiating U.S. Phase 3 Clinical Study
Published May 11th, 2022
Spine BioPharma, Inc.,a company committed to developing non-opiate, non-surgical therapies for the treatment of chronic low back pain (CLBP) caused by degenerative disc disease (DDD), today announced the receipt of a U.S. Food and Drug Administration (FDA) Study May Proceed Letter authorizing the Company to proceed with a Phase 3 clinical study of SB-01 For Injection (SB-01). SB-01 is the first pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with DDD.
Approximately 22.5 million Americans are diagnosed with CLBP-DDD annually (Ravindra 2018). Despite the significant need for innovative therapies, CLBP patients are left with few effective treatment options. CLBP is the top two reason for opioid prescriptions (Hudson 2008), which carry addiction risk and other serious side effects. CLBP patients currently have no alternative but to undergo surgery at a high dollar cost, long recovery period, and an unpredictable outcome.
SB-01 is a 7-amino acid peptide that binds to and antagonizes TGFβ1 activity. TGFβ1 is an inflammatory cytokine which is often highly expressed in the degenerated discs (Peng 2006). TGFβ1 signaling is associated with inflammation, pain mediation and the degradation of extracellular matrix which maintains the structural integrity of spinal discs. SB-01 treatment consists of a single intradiscal injection of the diseased disc and antagonizes the overexpression of TGFβ1, which decreases inflammation, pain mediation and supports the production of extracellular matrix, which maintains the structural integrity of the spinal disc (Kwon 2013).
Marc Viscogliosi, CEO of Spine BioPharma, stated, “This is an important achievement for the Company, and a significant milestone for all stakeholders interested in chronic low back pain. The initiation of this Phase 3 comes after a decade of pioneering scientific discovery, extensive non-clinical, and two large, prospective, randomized clinical studies. We are grateful for the support of our partners to get to this stage, including Yuhan Corp., Ensol Biosciences, Almac Group, Emergent BioSolutions, and MCRA.”
Dr. Christopher Gilligan, Principal Investigator of the Phase 3 Study, who is Associate Chief Medical Officer at Brigham and Women’s Hospital and Assistant Professor of Anaesthesia at Harvard Medical School, stated, “The clinical trial, known as the MODEL Study (Moderate-Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) is a landmark study. The trial design offers, for the first time, the opportunity to test whether a single intradiscal injection will provide patients with six months of clinically meaningful symptomatic relief.”
Dr. Fran Magee, CTO of Spine BioPharma, stated, “There has been enthusiastic interest from physician investigators and we are excited to begin our Phase 3 clinical study. We are actively recruiting 30 clinical sites to participate in the study, which will enroll 400 patients.”
About Degenerative Disc Disease
Approximately 266 million (Ravindra 2018) individuals around the world experience Degenerative Disc Disease, (DDD), and its associated Chronic Low Back Pain each year. DDD of the lumbar, (lower, spine) is a significant cause of disability in the world and a tremendous expense to the healthcare system. It is associated with a variety of clinical symptoms, including, pain, weakness, and pain-related disability of varying levels of severity. There is currently no treatment for DDD and current approaches are aimed at managing symptoms through a variety of approaches that include physical therapy, chiropractic care, non-steroidal anti-inflammatory drugs (NSAIDS) or prescription opioids. For patients with moderate-severe pain that persists chronically, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefit. Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved treatment with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care.
About Spine BioPharma
Spine BioPharma specializes in non-surgical therapies that will reduce pain, restore function and slow or stop pathological spinal disease progression without the use of opioids. Spine BioPharma’s lead candidate, SB-01, is a first-in-class, therapeutic for the treatment of degenerative disc disease, offering clinical benefits of pain relief, restoration of function and potential prevention of disease progression. SB-01 has also been referred to YH14618 by Yuhan Corp. and P2K by Ensol Biosciences.
Ravindra et al., Global Spine Journal. 2018. 8(8):784-794.
Hudson et al., Pain and Symptom Management. 2008. 36(3):280-288.
Peng et al., Spine (Phila Pa 1976). 2006. 31(5):560-6.
Kwon YJ et al., Spine (Phila Pa 1976). 2013. 38(2):E49-58.