ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury

NEW HAVEN, Conn.June 19, 2019 /PRNewswire/ — ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company’s Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204.

Recruitment will begin immediately for the Phase 1 first-in-human trial of AXER-204 for the treatment of chronic spinal cord injury (SCI). The “RESET” Trial will assess safety, tolerability, pharmacokinetics, and efficacy in patients at leading SCI treatment centers across the U.S. An estimated 300,000 people are currently living with chronic SCI in the U.S., and there is currently no approved therapeutic to restore sensory or motor function after injury. An effective therapeutic to promote recovery of function after damage would be the first of its kind to address a significant and completely unmet medical need.

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2 Responses to ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury

  1. Rebecca Baudains says:

    Is there any way of being involved living outside of America?

    • christalpowell says:

      Not that I am aware of. I’ll watch and will let you know if other countries become involved in the trials.

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