FDA Greenlights New Treatment for Chronic Back Pain

FDA Approves Phase III Study for Innovative Back Pain Therapy

DiscGenics, a biopharmaceutical company, recently received U.S. FDA approval to begin Phase III trials of its new treatment for lumbar degenerative disc disease (DDD). This cell-based therapy, called injectable disc progenitor cell therapy (IDCT), aims to provide a regenerative alternative for patients suffering from this painful condition.

The decision came after reviewing DiscGenics' comprehensive clinical protocols and development plans. This approval allows the company to start its pivotal and confirmatory studies, both crucial for assessing the therapy's effectiveness and safety.

Details of the Clinical Trial

The upcoming Phase III studies will run concurrently and include patients experiencing single-level symptomatic lumbar intervertebral disc degeneration. These trials are designed to be randomized, double-blind, and Sham-controlled to ensure robust data collection and analysis.

The pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM) will each have primary endpoints at the one-year mark, followed by an additional year of observation. The first participant in these studies is expected to be enrolled by Q4 2024.

Expert Opinions and Future Expectations

According to Dr. Nagy Mekhail from the Cleveland Clinic, existing treatments for mechanical back pain are limited. He expressed optimism about IDCT’s potential to revolutionize how degenerative disc disease is treated, offering a less invasive and more regenerative option compared to traditional surgeries.

DiscGenics’ Chief Medical Officer, Kevin T. Foley, also emphasized that the upcoming trials build on a strong foundation of earlier clinical data showing both safety and efficacy.

What is IDCT?

IDCT is an injectable, biologic treatment offering a one-time solution for lumbar disc degeneration. The drug uses a population of progenitor cells derived from donated human intervertebral disc tissue, which are then enriched and expanded under strict manufacturing standards.

These cells are mixed with a Sodium Hyaluronate Solution and other excipients to create the final drug product, which is then cryopreserved and stored for use. IDCT aims to both halt the progression of degeneration and stimulate disc regeneration.

Impact of Lumbar Degenerative Disc Disease

Degenerative disc disease causes chronic low back pain—a major condition affecting millions in the U.S. It is not just a leading cause of disability but also a significant contributor to the opioid crisis as many people rely on these drugs for pain management.

By providing a new, effective treatment, IDCT has the potential to reduce the economic burden on the healthcare system and improve the quality of life for patients.

Looking Ahead

DiscGenics was founded on pioneering cell technology developed by Dr. Valery Kukekov. Over the years, the company has remained committed to advancing this groundbreaking treatment, achieving significant milestones along the way.

Eventually, the success of the Phase III trials could lead to a Biologics License Application (BLA) being filed with the FDA, bringing this much-needed treatment one step closer to becoming available to the public.