Principle Investigator: Seth Schulman, MD
Performing Organization: Neuraptive Therapeutics, Inc.
Objectives and Rationale: The primary objective of the proposed grant is to support a Phase 3 clinical study comparing a new treatment for peripheral nerve repair, NTX-001, against the standard of care (SOC) treatment alone. The results of this study, in addition to the results from other studies, will be used to demonstrate the safety and efficacy of NTX-001 for peripheral nerve repair to the US Food and Drug Administration. This is the final study required to be submitted for regulatory approval to ensure the product is available to improve outcomes for patients with peripheral nerve injuries.
Prior research indicates that the use of NTX-001 will improve the speed and amount of recovery from transected nerve injuries in the arms and legs. These injuries can lead to significant long- term disabilities such as partial paralysis and chronic pain, resulting in difficulty or inability to perform daily activities. The natural cellular healing process includes the breakdown of the part of the nerve further from the injury (toward the hand or foot) and regrowth from the injury site. This is a very slow process. Often by the time the new nerve has regrown, the muscle it would innervate has broken down to the point that a new connection cannot be made. The current treatment for repairing nerve injuries focuses on reconnecting the nerves surgically but does not address the process of nerve breakdown after injury. NTX-001 improves the ability for the cut nerves to fuse immediately when they are surgically repaired, which can result in better and faster healing and potentially improve the patient’s recovery and overall quality of life.
This study will involve around 100 participants who will receive either the SOC surgical repair or the new treatment combined with the SOC. Their recovery will be evaluated with both patient- reported metrics as well as objective assessments to determine the effectiveness and safety of NTX-001. The surgeons performing the repairs will know which patients are in the treatment or control group, however, the patients themselves and those performing the evaluations will be blinded as to who received NTX-001 or SOC alone.
Ultimate Applicability and Impact of the Research: Peripheral nerve injuries occur in both civilian and military settings and in people of all ages and genders. By improving the speed and quality of nerve healing, NTX-001 can help these patients regain their extremity function and reduce acute and chronic pain, which may allow them to return more fully to their daily activities and work. The faster recovery times and improved outcomes will also reduce the need for long- term medical care and rehabilitation, easing the burden on healthcare systems and improving the overall quality of life.
For military personnel, particularly those injured in combat, NTX-001 could be a significant paradigm shift. Peripheral nerve injuries are common in combat scenarios due to the nature of modern warfare and the use of body armor that protects vital organs but leaves limbs exposed and vulnerable to injury. Faster and more complete recovery from these injuries means that warfighters can return to active duty sooner and with fewer complications. Additionally, reducing the long-term disabilities associated with these injuries can help veterans reintegrate into civilian life, reducing unemployment and improving mental health outcomes.