ReNetX Bio Receives Fast Track Designation From U.S. FDA

Published: January 8, 2020  |  Source: globenewswire.com
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Potential First-in-Class Therapy for Chronic Spinal Cord Injury

NEW HAVEN, Conn., Jan. 08, 2020 (GLOBE NEWSWIRE) — ReNetX Bio announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for ReNetX Bio’s clinical therapy (AXER-204) for the potential treatment of Chronic Spinal Cord Injury (SCI).  ReNetX Bio is currently conducting a Phase 1/2 clinical trial “RESET” in patients with SCI, with topline results expected in 2021.

SCI is a serious and currently incurable medical condition which causes profound deficits in function and impairs the ability to carry out activities of daily living (ADLs) and affects roughly 300,000 people in the United States. In addition to profound persistent neurological impairment, patients with chronic SCI suffer a variety of other health consequences including respiratory complications, cardiovascular complications, urinary and bowel complications, spasticity, pain syndromes, pressure ulcers, osteoporosis, and bone fractures.

Treatment for chronic SCI consists primarily of physical and/or occupational therapy.  Recovery from SCI after the first few weeks following injury is limited, as axonal growth is virtually non-existent in the adult spinal cord.  “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.”

About Fast Track Designation
As one of its Expedited Programs for Serious Conditions, the FDA grants Fast Track Designation to “facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need” in order to make important new drugs available to patients earlier. According to the FDA, a drug that receives Fast Track Designation is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
  • Eligibility for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

About the Phase 1/2 RESET Study:
For more information, please visit ClinicalTrials.gov.

About ReNetX Bio, Inc.:
For more information, please visit www.renetx.com