Milestone for RESET Study
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In November 2021, ReNetX Bio, the privately held, clinical-stage company announced the completion of enrollment in part two of their RESET study. This is a tremendous, good news given the fact how hard it is to complete recruitment for a clinical trial in general and even more in times of pandemic.
This gives hope to the community of chronic spinal cord injury patients. ReNetX Bio committed to reversing disease and damage for patients suffering from central nervous system disorders. The study lays the foundation for the molecule AXER-204 as a targeted approach to broadly address axonal damage. It is applied via intrathecal infusions at the level of the lumbar spine.
The current approach goes back to the early 2000s. Stephen Strittmatter, Director of Yale’s Department of Cellular Neuroscience, Neurodegeneration and Repair has been working on a mechanism to let nerve fibers reconnect and sproutd again. He zeroed in on three proteins of interest: Nogo-A, MAG and OMgp. All of them limit the ability of nerve fibers to grow. Strittmatter`s team found a receptor for these proteins and created a decoy—dubbed the Nogo Trap—that prevents the nerve fiber receptors from seeing the inhibitors.
The RESET study
The RESET study is a multiple dose, double-blind, placebo-controlled study to confirm safety and tolerability, and to investigate the efficacy of AXER-204 for chronic cervical spinal cord injury.
In part one of the trial, which entailed evaluating single ascending doses of AXER-204, a total of 24 participants received AXER-204. Part two of the trial comparing multiple doses of AXER-204 with placebo enrolled 27 participants at six major spinal cord injury treatment and rehabilitation centers in the United States.
Exciting results expected in 2022
Effectiveness is measured by internationally used motor scores reflecting the function of key muscle groups in the hands and arms. ReNetX Bio has powered the study for proof of concept and anticipates unblinding and reporting top line data in the second half of the year 2022.
This study is supported by Wings for Life and the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.
More details can be found on the press release by ReNetX Bio, Inc..
You can find out more on the spinal cord and the influence of its damage on the human body in our basic-information. Wings for Life Glossary gives an understanding of scientific terms.