SCB-01A

NEW YORK, July 10, 2024 /PRNewswire/ -- Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of pain related disabilities, today announced that it has signed an agreement with Korean Company Ensol BioSciences, Inc. to expand the indications (treatment scope) of its therapeutic drug treatment candidate, SB-01 For Injection. The agreement, valued at a total of $155 million, grants Spine BioPharma the exclusive rights to develop and commercialize SB-01 For Injection, for all additional indications beyond spine-related diseases, such as Osteoarthritis, fibrotic diseases, and Oncological indications. In 2018, Spine BioPharma acquired the right to develop and commercialize SB-01 For Injection globally excluding Korea, from South Korean pharmaceutical and chemical company, Yuhan Corporation (who had originally licensed it from Ensol BioSciences). Spine BioPharma is currently conducting its SB-01 Phase 3 MODEL Study ( Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with Degenerative Disc Disease (DDD) and anticipates completing trial enrollment of the 400-patient study in September 2024. (Clinicaltrials.gov: NCT05516992). Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are very pleased to have finalized this agreement with Ensol BioSciences, and excited about the future portfolio expansion opportunities it provides, beyond spine-related diseases. This agreement, coupled with the anticipated conclusion of the SB-01 Phase 3 MODEL Study enrollment, certainly broadens Spine BioPharma's strategic framework considerations to address the unmet needs of patients suffering from pain related disabilities, and beyond". About SB-01 For Injection SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, hypertension, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects. Considering this mechanism of action, SB-01 has potential in the treatment of other diseases beyond degenerative disc disease including osteoarthritis, fibrotic diseases, and other significant unmet medical needs. About Spine BioPharma Spine BioPharma is committed to developing non-surgical/non-opioid treatments that will reduce pain, restore function, and slow or stop pathological disease progression. Spine BioPharma's lead candidate, SB-01 For Injection, is a first-in-class treatment of degenerative disc disease, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit . Contact: Jason Gallagher Chief Commercial Officer & Chief Operating Officer [email protected] Office phone: (212) 583-9700 SOURCE Spine Biopharma, Inc

SB-01 For Injection Offers New Potential Treatment for Patients Suffering from Chronic Low Back Pain NEW YORK, Sept. 7, 2022 /PRNewswire/ -- Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of Chronic Low Back Pain (CLBP) and related disability caused by Degenerative Disc Disease (DDD), today announced the first patient treated in a Phase 3 clinical study of SB-01 For Injection (SB-01). The SB-01 Phase 3 study is known as the MODEL Study ( Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine). SB-01 is the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with DDD. The patient was treated at Conquest Research in Winter Park, FL where Dr. Malisa Agard is the Principal Investigator. The Phase 3 study of SB-01 is being conducted at 30 investigational sites across the US, enrolling up to 400 patients (Clinicaltrials.gov: NCT05516992). Approximately 22.5 million Americans are diagnosed with CLBP-DDD annually (Ravindra 2018). Despite the significant need for innovative therapies, CLBP patients have few effective treatment options. CLBP is the second most common reason for chronic opioid use (Hudson 2008), which carry addiction risk and other serious side effects. Currently, CLBP patients after years of palliative treatment, have no alternative but to ultimately undergo surgery at a high dollar cost, long recovery period, and an unpredictable outcome. SB-01, offers the potential, for the first time, a DDD treatment where a single intradiscal injection could provide patients with six months of clinically meaningful symptomatic relief. 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). High TGFβ1 levels within a diseased disc is associated with inflammation, pain mediation, and the degradation of extracellular matrix, causing the disc to lose structural integrity. 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 promotes the production of extracellular matrix, which improves the structural integrity of the diseased disc (Kwon 2013). Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are pleased to have treated our first patient in the SB-01 MODEL study and we look forward to enrolling additional patients across all the investigational sites." 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 (CLBP) 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 is committed to developing non-surgical/non-opioid treatments that will reduce pain, restore function, and slow or stop pathological spinal disease progression. Spine BioPharma's lead candidate, SB-01 For Injection, is a first-in-class treatment of degenerative disc disease, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit . Contact: Marc Viscogliosi [email protected] (212) 583-9700 SOURCE Spine Biopharma, Inc