Regenerating Discs or Selling Dreams? The High-Stakes Race to Cure Back Pain
- Kaleidoscope Marketing
- Mar 13, 2025
- 4 min read
Degenerative Disc Disease (DDD) impacts up to 250 million people globally, making an effective regenerative treatment one of the holy grails in musculoskeletal medicine. Earlier this week, I attended the Canaccord Genuity Orthopedic Technology Conference in San Diego and had the privilege of hearing updates from two standout companies that deserve a place on your watch list. Both have made remarkable strides toward delivering transformative therapies capable of significantly improving the lives of millions of patients suffering with DDD. Special thanks and recognition to Caitlin Cronin and the entire CG team for hosting another exceptional event.
Spine BioPharma
History
Founded in 2015 and headquartered in New York, Spine BioPharma is a development-stage company dedicated to creating non-opiate, non-surgical therapies for degenerative spine diseases. The company's mission centers on improving the lives of individuals suffering from chronic low back pain associated with degenerative disc disease (DDD) by offering innovative therapeutic solutions.
Technology
Spine BioPharma's flagship product, SB-01 For Injection, is a synthetic 7-amino acid peptide designed to antagonize Transforming Growth Factor-Beta (TGF-Beta) activity. TGF-Beta is a cytokine implicated in various pathological processes, including inflammation, fibrosis, and nerve hyperexcitability. By modulating TGF-Beta concentrations, SB-01 aims to mitigate these adverse effects, potentially offering pain relief, functional restoration, and inhibition of disease progression in DDD patients.
Clinical Pathway and Trial Updates
Spine BioPharma has been actively advancing SB-01 through rigorous clinical evaluations:
Phase 3 MODEL Trial: In September 2024, the company completed enrollment for its Phase 3 MODEL (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) trial, involving 417 patients across 30 U.S. sites. This randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of SB-01 in treating chronic low back pain due to DDD.
Expansion of Indications: In July 2024, Spine BioPharma entered into an agreement with Ensol BioSciences to broaden the therapeutic applications of SB-01 beyond spine-related diseases to conditions such as osteoarthritis and fibrotic diseases. This strategic move underscores the potential versatility of SB-01 in addressing various medical needs.
Future Outlook
Spine BioPharma is poised to revolutionize the treatment landscape for DDD and related conditions. Pending positive outcomes from the Phase 3 MODEL trial, SB-01 could become the first intradiscal pharmacologic treatment approved for chronic low back pain associated with DDD. The company's commitment to expanding SB-01's indications further highlights its dedication to addressing unmet medical needs through innovative therapies.
DiscGenics
History
Established in 2008, DiscGenics is a privately held, clinical-stage biopharmaceutical company specializing in regenerative cell-based therapies for degenerative spinal diseases. The company was co-founded by Dr. Valery Kukekov, a scientist renowned for his work in stem cell biology, and Dr. Kevin Foley, who needs no further introduction for those of us who have been in spine for any length of time. Their combined expertise has been instrumental in pioneering treatments aimed at alleviating pain and restoring function in patients with degenerative disc conditions.
Technology
DiscGenics' lead product candidate, Injectable Discogenic Cell Therapy (IDCT or rebonuputemcel), is an allogeneic, injectable cell therapy derived from discogenic progenitor cells. These specialized cells are engineered to address the complex environment of degenerated intervertebral discs, aiming to reduce inflammation, promote tissue regeneration, and restore disc function.
Clinical Pathway and Trial Updates
DiscGenics has made significant strides in the clinical development of IDCT:
Phase 1/2 Clinical Trial: In February 2022, interim data from this trial demonstrated that IDCT was well-tolerated and led to clinically meaningful, statistically significant improvements in low back pain, function, and quality of life by 12 weeks post-injection. These improvements were sustained at the one-year mark, with further data collection ongoing.
Two-Year Clinical Data: By January 2023, DiscGenics reported positive two-year outcomes, indicating that IDCT not only increased disc volume but also provided rapid and durable improvements in pain and function. Importantly, no serious treatment-emergent adverse events were observed, underscoring the therapy's safety profile.
FDA Approval for Phase 3 Trials: In July 2024, the U.S. Food and Drug Administration granted approval for DiscGenics to proceed with Phase 3 clinical evaluation of IDCT. This program includes two parallel, randomized, double-blind, sham-controlled studies targeting patients with symptomatic lumbar DDD. Success in these trials could pave the way for a Biologics License Application (BLA) submission.
Future Outlook
DiscGenics is at the forefront of developing regenerative therapies for spinal conditions. With the advancement to Phase 3 clinical trials, the company is well-positioned to potentially offer a minimally invasive, regenerative treatment option for patients suffering from degenerative disc disease. The successful development and commercialization of IDCT could significantly impact the standard of care for chronic back pain, providing patients with alternatives to surgical interventions.
Both Spine BioPharma and DiscGenics are pioneering innovative therapies with the potential to revolutionize the treatment landscape for degenerative disc disease and chronic low back pain. Their ongoing clinical trials and technological advancements could profoundly impact millions of patients seeking effective, non-surgical relief from debilitating spine-related conditions.
However, significant questions remain regarding the long-term durability of patient outcomes. Spine BioPharma is evaluating patients for up to 52 months, while DiscGenics' published Safety and Preliminary Efficacy study extended to 104 weeks. To be clear, for patients who have exhausted all other non-surgical options, even a year or more of meaningful pain reduction would represent a considerable clinical victory. Moreover, it is conceivable that subsequent treatments with these therapies could extend these benefits even further (more research needed). Ideally, though, the true promise of these therapies lies in their regenerative potential, offering lasting relief and sustained improvement in quality of life.
One observation from the DiscGenics study caught my attention—specifically, their claim of improved disc height as depicted in the image published in the IJSS article. While this is certainly an ambitious objective in the context of DDD, I must acknowledge that, as a non-radiologist, the presented imaging evidence appears subtle, and any changes could potentially be attributed to slight variations in the imaging slice location. Nonetheless, the theoretical rationale behind disc regeneration remains compelling, and I sincerely hope the approach proves successful in restoring disc height.
In closing, congratulations to both companies on navigating the long and challenging road to innovation. We look forward to watching your continued progress as you approach what we all hope will be the final sprint to the finish line.
