DiscGenics has reported positive interim results from its ongoing Phase I/II clinical trial of injectable discogenic cell therapy (IDCT) (rebonuputemcel) to treat degenerative disc disease (DDD).
A homologous, allogeneic, injectable cell therapy, IDCT uses discogenic cells that are biomedically engineered progenitor cells obtained from intervertebral disc tissue of humans.
The multicentre, double-blinded, prospective, randomised, vehicle- and placebo-controlled trial is designed to analyse the safety and efficacy of IDCT in people with single-level, symptomatic lumbar intervertebral disc degeneration.
It is progressing in 14 trial sites in 12 US states and has concluded enrolment of all 60 participants without any safety issues observed so far.
Participants were categorised into one of four treatment arms to receive a single intradiscal dose of either low dose IDCT, high dose IDCT, vehicle alone or saline placebo.
Safety and pain reduction are the primary outcome measures of the trial while secondary outcome measures comprise radiographic improvement and decline in disability.
Findings showed that the primary efficacy endpoint was met, with high dose IDCT arm demonstrating statistically significant improvement in back pain.
Furthermore, the high dose IDCT resulted in clinically meaningful, statistically significant enhancements in function as assessed by the Oswestry Disability Index (ODI) and quality of life as evaluated by the EQ-5D Index Score at these same time points.
IDCT was well tolerated in the trial with no serious treatment-emergent adverse events (TEAEs) reported in subjects who received the cell therapy.
At one-year following treatment, the improvements in function, pain and quality of life surpassed minimum clinically important differences (MCIDs), which indicate meaningful variations in clinical intervention for the subject.
Currently, the company is assessing results from subject follow-up visits at weeks 78 and 104.
The complete dataset will be submitted by DiscGenics to the Office of Tissues and Advanced Therapies (OTAT) of the FDA for consideration in an End of Phase II meeting anticipated in the second half of this year.
DiscGenics chief medical officer Kevin Foley said: “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.”
In March 2020, the company concluded subject enrolment in its Phase I / Phase II trial of IDCT for the treatment of DDD in the US.
Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.
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