Positive Clinical Data from Phase I/II Study of Cell Therapy for Degenerative Disc Disease Report DiscGenics
The clinical stage biopharmaceutical company DisGenics, have announced that their FDA fast track designated cell therapy to target degenerative disc disease (DDD) – IDCT (rebonuputemcel) – has shown positive interim data in its ongoing Phase I/II clinical trial.
DiscGenics develop regenerative cell-based therapies to treat degenerative diseases of the spine, restoring function and reducing pain. IDCT is the company’s first product to be built using their proprietary Discogenic Cell Platform. This platform sees the production of allogenic cell therapies derived from intervertebral disc cells from donated adult human tissue. These progenitor cells then undergo biomedical engineering forming the discogenic cells. The cells are then reproducibly manufactured to a therapeutic scale under cGMP controls, subjected to safety analysis, combined with a delivery vector and cryopreserved. The off-the-shelf IDCT can then be administrated to patients via injection.
DisGenics reported at the Spine Summit 2022 they have observed a statistically significant improvement in back pain in those who received a high dose of ICDT in the ongoing trial, when considering data at the time points of 12, 26 and 52 weeks post IDCT injection. They also presented clinically meaningful improvements in function at these same time points, measured using the Oswestry Disability Index and quality of life EQ-5D Index Score.
When considering minimum clinically important differences at the one-year post-injection – in terms of function, pain and quality of life – all statistical data exceed these, with no participants experiencing treatment-emergent adverse effects.
“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,” comments Kevin T. Foley, CMO of DiscGenics and Chairman of Semmes-Murphy Neurologic & Spine Institute.
As the analysis of the 78 and 104-week patient data currently takes place, DisGenics looks towards submitting the full Phase II dataset to the FDA Office of Tissues and Advanced Therapies in the second half of 2022.
“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” says Flagg Flanagan, CEO and Chairman of the Board for DiscGenics.
Source:DiscGenics Press Release