Spine BioPharma Announces First Patient Treated in U.S. Phase 3 Clinical Study

2022-09-07

合作First in Class

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 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 www.spinebiopharma.com.

Contact:

Marc Viscogliosi

[email protected]

(212) 583-9700

SOURCE Spine Biopharma, Inc