Spine BioPharma Completes Enrollment for Critical Clinical Trial
Spine BioPharma's Remarkable Clinical Trial Progress
Spine BioPharma, Inc. has taken significant steps in the realm of non-opiate, non-surgical therapies for Degenerative Disc Disease (DDD). The company announced that it has successfully completed enrollment in its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01). This milestone marks a crucial advancement in addressing chronic low back pain (CLBP), a condition that affects millions of individuals.
The MODEL Trial: A Comprehensive Approach
The Phase 3 MODEL trial, which stands for Moderate-Severe Degenerative Disc Disease Evaluation of the Lumbar Spine, enrolled a total of 417 patients across 30 investigational sites throughout the U.S. over the course of two years. This trial is notable as SB-01 represents the first intradiscal pharmacologic treatment to enter Phase 3 studies specifically targeting chronic low back pain and its associated functional impairments stemming from DDD.
Statements from Leadership
Marc Viscogliosi, CEO of Spine BioPharma, emphasized the significance of this development in the context of patient care, stating, “This is an important milestone for the patient and physician community, and for the Company. After years of conservative treatment, DDD patients often face the difficult choice of surgery, which can be costly and comes with unpredictable outcomes.” He also expressed satisfaction with the early enrollment completion, stating it brings SB-01 closer to fulfilling the unmet needs of millions.
Contributions Recognized
Fran Magee, DVM, Chief Technology Officer, remarked on the importance of collaboration during this trial. “We would like to thank the patients, clinical trial site staff and physicians, and our vendor partners for their participation in this landmark trial. The insights from the data collected may illuminate treatment challenges and offer a potential new therapeutic option for DDD patients.”
The Scope of Degenerative Disc Disease
Degenerative Disc Disease is a widespread condition, affecting approximately 266 million people globally, with an estimated 22.5 million Americans diagnosed each year. This condition remains challenging to treat, with current options primarily focused on symptom management through physical therapy, NSAIDs, chiropractic care, or opioid prescriptions. For chronic moderate-to-severe cases, other interventions like epidural steroid injections, radiofrequency ablation, and surgical options may be considered, albeit with varying efficacy and significant risks.
Understanding the MODEL Clinical Trial
The SB-01 MODEL trial is a pivotal multi-center, randomized, double-blind, placebo-controlled study aimed at establishing both the safety and efficacy of SB-01 For Injection. This treatment is targeted toward adult patients suffering from chronic low back pain and related impairments due to lumbar DDD.
Insights into SB-01 For Injection
SB-01 consists of a 7-amino acid synthetic peptide designed to bind and modulate TGF-Beta activity. TGF-Beta is a crucial cytokine involved in numerous cellular processes, and its dysregulation can lead to negative effects, including inflammation and nerve hyperexcitability. With SB-01, the aim is to balance TGF-Beta levels, mitigating adverse effects while preserving its beneficial roles.
About Spine BioPharma
Spine BioPharma’s mission is focused on developing innovative, non-opiate, and non-surgical treatments that aim to alleviate pain, restore functionality, and slow or halt disease progression. Their flagship candidate, SB-01 For Injection, holds promise as a transformative treatment for DDD, potentially offering clinical advantages in pain relief, function restoration, and disease management.
Frequently Asked Questions
What is the primary goal of the SB-01 clinical trial?
The primary goal is to evaluate the safety and effectiveness of SB-01 for treating chronic low back pain associated with Degenerative Disc Disease.
How many patients were involved in the trial?
A total of 417 patients participated in the trial across 30 investigational sites in the U.S.
What is the significance of the completion of enrollment?
Completing enrollment signifies a crucial step towards developing a potential new treatment option for those suffering from chronic low back pain, addressing an unmet medical need.
What differentiates SB-01 from traditional therapies?
SB-01 offers a targeted pharmacologic approach, which is different from traditional therapies that primarily aim at symptom management without treating the underlying causes of DDD.
What future implications does this trial have for patients?
If successful, the trial outcomes could provide a new therapeutic avenue for millions suffering from chronic low back pain and improve overall patient care in this area.
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