DiscGenics is engaged in developing regenerative cell-based therapies to relieve pain and reinstate function in patients with degenerative diseases of the spine
DiscGenics, a clinical stage biotechnology company, announced the first patients have been treated in its Japanese safety study, a clinical trial of Injectable Disc Cell Therapy (IDCT) for mild to moderate degenerative disc disease (DDD).
DDD is a painful, chronic and progressive disease characterized by inflammation and breakdown of extracellular matrix within the intervertebral disc.
Associate professor in orthopaedic surgery at the Tokai University School of Medicine and the principal investigator of the study Dr Daisuke Sakai has treated the first patient.
Sakai said: “I am excited to be participating in the clinical evaluation of IDCT as a potential cell therapy to treat degenerative disc disease. I am encouraged by my preclinical observations of IDCT’s human Discogenic Cells in a canine disc degeneration model that demonstrated the ability to stop disc height degeneration while improving the structure of the intervertebral disc.
“If we can achieve similar results in human subjects, the result could be reduced pain and disability associated with DDD.”
IDCT is a homologous, allogeneic, injectable cell therapy
IDCT makes use of Discogenic Cells, a biomedically engineered progenitor cells derived from intervertebral disc tissue, to offer a non-surgical, potentially regenerative solution for the treatment of mild to moderate DDD.
DiscGenics said that the prospective, randomised, double-blinded, sham-controlled study is aimed at evaluating the safety and preliminary efficacy of IDCT at two dosage levels in subjects.
In addition, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has supported the trial through approval of a Clinical Trial Notification (CTN) application for IDCT, issued in 2018.
DiscGenics chief executive officer and board of directors’ chairman Flagg Flanagan said: “Commencing clinical evaluation of our first product candidate in Japan is a significant milestone for DiscGenics as we continue to advance IDCT as a potentially revolutionary treatment for DDD.
“With IDCT, we have an opportunity to serve Japan’s aging population by providing a novel, interventional therapy for DDD, one of the most common causes of chronic low back pain and a well-known unmet medical need.”
DiscGenics intends to conduct the trial in six centres across Japan enrolling 38 subjects, who meet all eligibility criteria. The subjects will be randomised to one of the three treatment cohorts, namely low dose IDCT, high dose IDCT and sham.
The company is also conducting an ongoing phase I/II prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicenter clinical trial of IDCT in the US.