CHESTERBROOK, PA — Neuraptive Therapeutics, Inc. announced the enrollment of the first patient in its phase 3 clinical trial evaluating NTX-001, an investigational therapy designed to improve outcomes in patients with peripheral nerve injuries caused by trauma.
The multicenter, randomized, subject- and evaluator-blinded study will compare the safety and efficacy of NTX-001 with the current standard of care, neurorrhaphy, for upper extremity transected nerves requiring surgical repair. Approximately 110 patients are expected to be enrolled across 24 clinical sites throughout the United States. Participants will be randomly assigned to receive either standard of care or NTX-001 as an adjunct therapy.
“Enrolling the first patient in our phase 3 trial marks a major milestone for Neuraptive and NTX-001 for patients who have sustained traumatic injuries requiring surgical repair,” said Seth Schulman, MD, Chief Medical Officer of Neuraptive. “We believe NTX-001 has the potential to set a new standard of care to address a significant unmet need, and this is another important step forward toward FDA approval.”
Dr. Katie Liu, Assistant Professor at the University of Washington Medical Center and Principal Investigator for one of the trial sites, noted the clinical significance of the research. “Our team is excited to be a part of this clinical trial which represents a significant step forward in developing innovative treatments to accelerate functional recovery for patients with peripheral nerve injuries,” she said.
NTX-001 has received both Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration. The phase 3 study is supported by a Fiscal Year 2024 Clinical Trial Award from the Armed Forces Institute of Regenerative Medicine (AFIRM), granted to Neuraptive through the Wake Forest Institute for Regenerative Medicine and funded by the Department of Defense’s Defense Health Agency Research and Engineering Directorate.
The funding is focused on advancing regenerative medicine technologies to treat traumatic battlefield injuries, including nerve and extremity damage—areas where NTX-001 may offer critical clinical benefits.
The views and conclusions presented in the announcement are those of the authors and do not necessarily represent official policies or endorsements of the U.S. Government.
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