Spine BioPharma, Inc., a development stage company committed to non-opiate, non-surgical therapies for Degenerative Disc Disease (DDD), today announced the completion of enrollment of its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01).

The Phase 3 MODEL trial (MOderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of chronic low back pain (CLBP) and its associated pain-related loss of function caused by DDD.

“This is an important milestone for the patient and physician community, and for the Company. 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,” said Marc Viscogliosi, CEO of Spine BioPharma. “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.”

Fran Magee DVM, Chief Technology Officer, stated: “We would like to thank the patients, clinical trial site staff and physicians, and our vendor partners for their participation in this landmark trial. We believe the insights from the data collected during this trial may help shed light on treatment challenges and potentially offer a clinically meaningful new therapeutic treatment option for DDD patients.”

Approximately 266 million individuals around the world experience DDD, and 22.5 million Americans are diagnosed with DDD, each year¹. There is currently no targeted treatment for DDD, and existing approaches are aimed at managing symptoms through physical therapy, chiropractic care, Non-steroidal Anti-inflammatory Drugs (NSAIDS) or prescription opioids. For patients with chronic moderate-severe DDD, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefits. CLBP is the second leading cause of chronic opioid use², which carries addiction risk and other serious side effects.

About the MODEL Clinical Trial

SB-01 MODEL clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 trial being conducted to establish the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and its associated impairment in pain-related function due to Lumbar DDD.

About SB-01 For Injection

SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity. 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, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects.

About Spine BioPharma

Spine BioPharma is committed to developing non-opiate, non-surgical 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 DDD, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit www.spinebiopharma.com

¹ Ravindra, Vijay, M., et al. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine Journal. v.8(8); 2018 Dec.

² Hudson, Teresa J., et al. Epidemiology of Regular Prescribed Opioid Use: Results from a National, Population-Based Survey. Journal of Pain and Symptom Management. 2008 Sep; 36(3): 280–288.

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