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.”