The first patient has been treated in DiscGenics Inc.’s prospective Phase 3 clinical trial evaluating IDCT (injectable disc cell therapy, rebonuputemcel) in patients with single-level, symptomatic mild-to-moderate lumbar degenerative disc disease (DDD). U.S. site activation currently is underway.

“Treating the first patient in our Phase 3 trial marks an important milestone for DiscGenics and for individuals living with lumbar degenerative disc disease,” DiscGenics Chief Medical Officer Kevin T. Foley, M.D., said. “Many patients today face a difficult choice between continuing conservative care that is no longer working or opting for invasive surgery. IDCT is designed to offer an effective alternative that is minimally invasive and requires a single injection in an outpatient setting. It is a cell-based option that targets the diseased disc itself. With this pivotal trial, we aim to generate the rigorous clinical evidence needed to be able to provide IDCT to patients suffering from symptomatic disc degeneration.”

DGX-A02 is a randomized, double-blind, sham-controlled, multicenter study designed to evaluate the safety and efficacy of IDCT in subjects with single-level, symptomatic mild-to-moderate lumbar (L3–S1) intervertebral disc degeneration. The trial is expected to enroll approximately 162 subjects and includes a 52-week primary period followed by a 52-week follow-up period (total 104 weeks).

“In my role as principal investigator at the top enrolling site for the Phase 1/2 trial, we saw promising results. I’m grateful for the opportunity to participate in the current Phase 3 trial to further evaluate what I believe to be a very promising treatment. We were excited to have treated the first study patient in the country,” stated Matthew F. Gornet, M.D., a spine surgeon at The Orthopedic Center of St. Louis. “Participating in this Phase 3 trial allows us to offer eligible patients access to an investigational therapy that is specifically designed to address the underlying disc pathology. We are pleased to be part of a study that could help expand future treatment options for this challenging condition.”

IDCT is an investigational, single-injection biologic treatment designed to halt the progression of lumbar disc degeneration and regenerate the disc from within. The active component of IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, delivered through a viscous carrier. IDCT has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA). IDCT has not been approved by the FDA or any other regulatory authority for any use.

“This Phase 3 trial has been carefully designed to evaluate both the safety and efficacy of IDCT using a randomized, double-blind, sham-controlled approach,” said Nagy Mekhail, M.D., Ph.D., Cleveland Clinic, and chief eligibility officer for the DGX-A02 pivotal trial. “The rigorous eligibility criteria and standardized assessments are intended to ensure a high-quality data set that can meaningfully inform clinicians, patients, and regulators about the role a targeted, cell-based therapy might play in the management of lumbar degenerative disc disease.”

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration. Its lead product candidate, IDCT (rebonuputemcel), is a single-injection biologic therapy designed to stop lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics has developed a proprietary, commercial-scale, in-house allogeneic cell manufacturing process and built a cGMP facility at its Salt Lake City, Utah, headquarters.