DiscGenics has announced 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).
The interim results of the study—which includes 60 participants and is designed to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT and two controls in subjects with chronic low back pain due to DDD at one lumbar level from L3 to S1—were presented at Spine Summit 2022 (23–26 February, Las Vegas, USA).
According to a company press release, the primary efficacy endpoint of the study was achieved, with statistically significant improvement in back pain observed in the high dose IDCT group. For these patients, low back pain scores improved by more than 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 and quality of life as measured by the EQ-5D index score. In addition, no subjects in the IDCT treatment groups experienced serious treatment-emergent adverse events.
Kevin Foley, chief medical officer at DiscGenics, said: “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. 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.”
Flagg Flanagan, DiscGenics’ chief executive officer and chairman of the board, added: “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.
“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 commercialisation, with the ultimate goal of improving the lives of millions of people suffering from the debilitating effects of chronic low back pain.”
The company is currently in the process of analysing data from patient follow-up visits at weeks 78 and 104.