DiscGenics, a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the first 30 subjects have been safely treated its first-in-human U.S. clinical study of IDCT, an allogeneic, injectable disc cell therapy for mild to moderate degenerative disc disease (DDD).

Upon completing enrollment of the first 30-subject cohort, an independent data safety monitoring committee (DSMC) conducted its second planned safety review and reported there were no safety issues. The DSMC recommended that the trial continue with no changes to the protocol.

Subjects in the first cohort (n=30) were randomly assigned to receive an intradiscal injection of the low dose IDCT study treatment, vehicle or placebo. With the low dose cohort complete, the first six patients in the high dose cohort (n=30) will now be treated based on random assignment into one of three arms: high dose IDCT study treatment, vehicle or placebo. Upon completion of that milestone, the DSMC will conduct a third planned safety review, which if passed in a manner similar to the first two safety reviews, will allow for the completion of patient enrollment in its U.S. clinical trial.

“We are delighted to have cleared the halfway mark in our first-in-human U.S. study of IDCT for DDD, and are thrilled that there were no issues reported in this comprehensive safety review of the first 30 patients treated,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “We are committed to protecting patient safety through adherence to a rigorous regulatory pathway that emphasizes both safety and efficacy. Because this is a blinded study where neither the treating clinicians nor the patients know what treatment is being administered, performing periodic safety checks ensures the ongoing safety of the product in a clinical setting. We continue to be very pleased that the safety profile witnessed in our preclinical experience with IDCT is being reflected in human patients.”

The IDCT trial is a prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration. The trial is underway in 14 centers across 12 states in the U.S. and will enroll 60 subjects. Those subjects who meet all eligibility criteria are being randomized to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10). Each subject receives a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period. Primary outcome measures include safety and reduction in pain. Secondary outcome measures include reduction in disability and radiographic improvement.

Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by the U.S. Food and Drug Administration (FDA) and will be regulated as a drug-biologic through a therapeutics biologics license application (BLA). Importantly, DiscGenics announced in August 2019 that the FDA granted Fast Track designation for IDCT as a potential treatment option for chronic low back pain.

IDCT is also being evaluated in a multicenter safety study in Japan, which is supported by a Clinical Trial Notification (CTN) approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

DiscGenics is a privately held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine.

Source: Company Press Release