DiscGenics, Inc., 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 the presentation of positive interim data from its ongoing Phase 1/2 clinical trial of IDCT (rebonuputemcel), an allogeneic injectable discogenic cell therapy for degenerative disc disease (DDD), at Spine Summit 2022.
The primary efficacy endpoint of the study (n=60) was achieved, with statistically significant improvement in back pain observed in the high dose IDCT group. For these patients, low back pain scores improved >30% as measured on a 100mm Visual Analog Scale (VAS) at Weeks 12 (–54.53% [–69.46, –39.60], p=0.0056), 26 (–50.94% [–66.10, –35.78], p=0.0140), and 52 (–62.79% [–77.13, –48.46], p=0.0005).
At these same timepoints, high dose IDCT also produced clinically meaningful, statistically significant improvements in function as measured by the Oswestry Disability Index (ODI) and quality of life as measured by the EQ-5D Index Score.
Importantly, no subjects in the IDCT treatment groups have experienced serious treatment-emergent adverse events (TEAEs).
“We are very encouraged by this interim clinical data. Not only are we seeing a strong safety profile and dramatic pain reduction with a dose response that occurs early and continues at the one-year time point in patients who received the high dose IDCT, we’re also seeing rapid, significant, and durable improvements in function and quality of life,” said Kevin T. Foley, M.D., Chief Medical Officer for DiscGenics and Chairman of Semmes-Murphy Neurologic & Spine Institute. “As we await the 78-week and 104-week final data readouts, we hope to see sustained and meaningful improvement in each of these life-changing measures.”
The improvements in pain, function, and quality of life at one-year post-injection exceeded what are known as minimum clinically important differences (MCIDs), which reflect changes in a clinical intervention that are meaningful for the patient.
“The significant and durable improvements we’re seeing in pain, function, and quality of life are critical indicators of the potential IDCT has to change the paradigm of care for patients with DDD,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “As stewards of this technology, the dedicated and talented team here at DiscGenics is working tirelessly to usher IDCT through the clinical and regulatory process to commercialization, with the ultimate goal of improving the lives of millions of people suffering from the debilitating effects of chronic low back pain.”
DiscGenics is in the process of analyzing data from patient follow-up visits at weeks 78 and 104. The Company intends to submit the full dataset to the U.S. Food & Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) for consideration in an End of Phase 2 meeting targeted for the second half of 2022.
In the meantime, DiscGenics is continuing to scale up its in-house manufacturing capabilities so it will have cells ready for future clinical and/or commercial application, depending on the outcome of the FDA’s review of the data.