Novel Therapy for Chronic Spinal Cord Injury Gets Fast Track Status
Diana Ernst, RPh
Fast Track designation allows for more frequent meetings with the FDA, as well as eligibility for accelerated approval and priority review.
The Food and Drug Administration (FDA) has granted Fast Track designation to AXER-204 (ReNetX Bio) for the potential treatment of chronic spinal cord injury.
AXER-204 is a human fusion protein that acts as a decoy for the myelin-associated inhibitors of axonal growth known as Nogo-A, MAG, and OMgp. The decoy receptor, known as Nogo Trap, is believed to bind to these inhibitors, thereby allowing the body to grow nerve fibers.
A phase 1/2 trial (RESET) is currently being conducted in 66 patients with traumatic spinal cord injury (≥1 year) to assess the safety, tolerability, pharmacokinetics, and efficacy of the treatment. During the double-blind phase, patients will be randomized to receive either AXER-204 administered by lumbar puncture and slow bolus infusion or placebo. Results of the study are expected sometime in 2021.
?This Fast Track designation from the FDA recognizes the high unmet medical need in patients with SCI,? said Erika R. Smith, MBA, CEO of ReNetX Bio. ?Fast track designation will help facilitate ReNetX Bio?s development of AXER-204, and potentially expedite future regulatory review of AXER-204 for patients with SCI.?
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According to recent guidelines, current treatment options for chronic spinal cord injury include neurotization or nerve bridging, neurostimulation/neuromodulation and neuroprosthesis, cell therapy, and neurorehabilitation. While some pharmaceutical therapies have shown benefit (ie, acidic fibroblast growth factor, granulocyte colony-stimulating factor), more studies are needed to confirm these results.
For more information visit renetx.com.
https://www.empr.com/home/news/drugs...7b1PZuYzX_qDhw
Diana Ernst, RPh
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Fast Track designation allows for more frequent meetings with the FDA, as well as eligibility for accelerated approval and priority review.The Food and Drug Administration (FDA) has granted Fast Track designation to AXER-204 (ReNetX Bio) for the potential treatment of chronic spinal cord injury.
AXER-204 is a human fusion protein that acts as a decoy for the myelin-associated inhibitors of axonal growth known as Nogo-A, MAG, and OMgp. The decoy receptor, known as Nogo Trap, is believed to bind to these inhibitors, thereby allowing the body to grow nerve fibers.
A phase 1/2 trial (RESET) is currently being conducted in 66 patients with traumatic spinal cord injury (≥1 year) to assess the safety, tolerability, pharmacokinetics, and efficacy of the treatment. During the double-blind phase, patients will be randomized to receive either AXER-204 administered by lumbar puncture and slow bolus infusion or placebo. Results of the study are expected sometime in 2021.
?This Fast Track designation from the FDA recognizes the high unmet medical need in patients with SCI,? said Erika R. Smith, MBA, CEO of ReNetX Bio. ?Fast track designation will help facilitate ReNetX Bio?s development of AXER-204, and potentially expedite future regulatory review of AXER-204 for patients with SCI.?
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According to recent guidelines, current treatment options for chronic spinal cord injury include neurotization or nerve bridging, neurostimulation/neuromodulation and neuroprosthesis, cell therapy, and neurorehabilitation. While some pharmaceutical therapies have shown benefit (ie, acidic fibroblast growth factor, granulocyte colony-stimulating factor), more studies are needed to confirm these results.
For more information visit renetx.com.
https://www.empr.com/home/news/drugs...7b1PZuYzX_qDhw
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