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Development of Nogo Receptor Decoy for the Treatment of Spinal Cord Injury

Axerion seeks to develop a therapeutic protein, Nogo Receptor Decoy [NgR(310)ecto-Fc], to promote the recovery of neurological function through axonal fiber growth after spinal cord injury. In nearly all neuropathies, a substantial portion of brain and spinal cord is preserved. If the remaining healthy tissue can be “rewired” with appropriate axonal connections, improved neurological function can occur.

Partial recovery from spinal cord injury may take place within the first few weeks after the injury. Additional recovery beyond that period is limited. This is because axonal growth, which is needed for greater recovery, is virtually nonexistent in the adult spinal cord. Treatment for chronic spinal cord injury, therefore, consists primarily of physical and/or occupational therapy. To date, no U.S. Food and Drug Administration (FDA)-approved therapeutic promotes new connections between surviving nerve cells. As a result, there is a significant unmet medical need for therapeutics that stimulate neurological recovery.

It has been demonstrated that NgR(310)ecto-Fc stimulates corticospinal and raphespinal axon growth. Additionally, it has been shown that functional recovery can be achieved in acute, subacute and chronic spinal contusion injuries with NgR(310)ecto-Fc therapy. Preclinical studies that demonstrate efficacy in an animal model of chronic spinal cord injury provide the basis for launching clinical trials of NgR(310)ecto-Fc therapy.

The goal of this project is to execute key activities necessary to support an investigational new drug (IND) application. Upon completion of these activities, an IND application will be submitted to the FDA, with clinical trials for the treatment of chronic spinal cord injury initiated soon afterward. The ultimate goal is to allow victims of chronic spinal cord injury to regain function and to improve their quality of life.

Key Investigators

Axerion Therapeutics, Inc.
George D. Maynard, Ph.D.

Public Health Impact

Axerion Therapeutics seeks to develop a therapeutic agent, Nogo Receptor Decoy, to promote the recovery of neurological function through axonal fiber growth after spinal cord injury. The NgR(310)ecto-Fc protein blocks the action of myelin inhibitors and allows axonal growth and functional recovery in rodent models.

Outcomes

Approved studies are ongoing.

Project Details

  • Synthesis of Good Manufacturing Practice-grade material
  • Formulation development
  • Pharmacokinetic/Absorption, Distribution, Metabolism, and Excretion (PK/ADME) studies
  • IND-directed toxicology

Contact

Tony Jackson