Spine BioPharma, Inc. Announces Completion of Enrollment for Phase 3 Clinical Trial of SB-01 to Address Chronic Low Back Pain

NEW YORK, September 24, 2024 –(BUSINESS WIRE)– Backbone BioPharma, Inc., a improvement stage firm dedicated to non-opiate, non-surgical therapies for Degenerative Disc Illness (DDD), right now introduced the completion of enrollment of its U.S. Section 3 medical trial of SB-01 For Injection (SB-01).

The Section 3 MODEL trial (MOderate – Extreme Degenerative Disc Illness Evaluation of the Lumbar Backbone) enrolled 417 sufferers at 30 investigational websites throughout the U.S., in a two-year interval. SB-01 is the primary intradiscal pharmacologic remedy to enter Section 3 research for the remedy of continual low again ache (CLBP) and its associatedpain-related lack of perform attributable to DDD.

“This is a vital milestone for the affected person and doctor neighborhood, and for the Firm. After years of conservative remedy, DDD sufferers don’t have any various however to in the end bear surgical procedure at a excessive greenback price, with lengthy restoration intervals and unpredictable outcomes,” stated Marc Viscogliosi, CEO of Backbone BioPharma. “We’re extraordinarily happy to have accomplished enrollment of the SB-01 MODEL trial forward of schedule. This accomplishment brings SB-01 one step nearer to addressing the unmet want of tens of millions of sufferers that suffer from CLBP related to DDD.”

Fran Magee DVM, Chief Expertise Officer, said: “We wish to thank the sufferers, medical trial web site workers and physicians, and our vendor companions for his or her participation on this landmark trial. We consider the insights from the info collected throughout this trial might assist make clear remedy challenges and probably provide a clinically significant new therapeutic remedy possibility for DDD sufferers.”

Roughly 266 million people around the globe expertise DDD, and 22.5 million People are identified with DDD, every year¹. There may be at present no focused remedy for DDD, and current approaches are aimed toward managing signs by means of bodily remedy, chiropractic care, Non-steroidal Anti-inflammatory Medication (NSAIDS) or prescription opioids. For sufferers with continual moderate-severe DDD, remedy plans embody epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Medical outcomes range and infrequently don’t present predictable advantages. CLBP is the second main explanation for continual opioid use², which carries habit threat and different critical unintended effects.

Concerning the MODEL Medical Trial

SB-01 MODEL medical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled Section 3 trial being performed to determine the protection and effectiveness of SB-01 For Injection in grownup sufferers with continual low again ache and its related impairment in pain-related perform resulting from Lumbar DDD.

About SB-01 For Injection

SB-01 is a 7-amino acid artificial peptide that binds to and antagonizes TGF-Beta exercise. TGF-Beta is a pleiotropic cytokine expressed by nearly each tissue and cell kind, is saved in abundance within the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In lots of ailments, there are excessive concentrations of TGF-Beta that end in a spectrum of destructive downstream results together with irritation, fibrosis, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta focus, with out eliminating it, mitigating the destructive downstream results.

About Backbone BioPharma

Backbone BioPharma is dedicated to growing non-opiate, non-surgical therapies that may cut back ache, restore perform, and sluggish or cease pathological illness development. Backbone BioPharma’s lead candidate, SB-01 For Injection, is a first-in-class remedy of DDD, providing potential medical advantages of ache reduction, restoration of perform, and prevention of illness development. To be taught extra about Backbone BioPharma, go to www.spinebiopharma.com

¹ Ravindra, Vijay, M., et al. Degenerative Lumbar Backbone Illness: Estimating World Incidence and Worldwide Quantity. World Backbone Journal. v.8(8); 2018 Dec.

² Hudson, Teresa J., et al. Epidemiology of Common Prescribed Opioid Use: Outcomes from a Nationwide, Inhabitants-Primarily based Survey. Journal of Ache and Symptom Administration. 2008 Sep; 36(3): 280–288.