Neuraptive Therapeutics, Inc. Announces Positive 24-Week Data for NTX-001 in the Phase 2 NEUROFUSE Study, Reinforcing Previously Announced Proof of Concept 12-Week Data

2024-02-22

临床2期临床结果

NTX-001 continues to be generally safe and well tolerated, with no additional adverse effects NTX-001 demonstrated a clinically and statistically significant improvement in function at 24 weeks. NTX-001 demonstrated a clinically and statistically significant improvement in pain at 24 weeks. WAYNE, Pa.--(BUSINESS WIRE)-- Neuraptive Therapeutics, Inc., a pioneer in nerve repair and regeneration, is proud to announce new 24-week data from the ongoing NEUROFUSE Study for NTX-001, further solidifying the product's status following the previously announced proof of concept results based on the 12-week data in January 2024. This press release features multimedia. View the full release here: Evan L. Tzanis, COO and EVP Head of R&D, Neuraptive Therapeutics, Inc. (Photo: Business Wire) The latest data from the multicenter, randomized, evaluator-blinded, Phase 2a NEUROFUSE Study underscores NTX-001’s sustained safety and efficacy as an adjunct treatment for transected peripheral nerves. At the 24-week mark, NTX-001 continues to demonstrate an encouraging safety profile, with lower treatment-emergent adverse event rates than the standard of care. Regarding efficacy, NTX-001 showed a statistically significant improvement in hand function and symptomatology as measured by the Michigan Hand Questionnaire (MHQ) compared to the standard of care alone, with clinically and statistically meaningful changes observed at eight and 24-week intervals. The secondary endpoints, including the Numerical Pain Rating Scale, also showed statistically significant improvements, favoring NTX-001 at the 24-week timepoint. These results validate the early clinical response reported at the 12-week interim time point and exhibit consistent, supportive trends across multiple secondary endpoints, including multiple assessments of sensory recovery. “Current techniques for the repair of traumatic peripheral nerve injuries often result in disappointing functional outcomes with the potential for significant neuropathic pain. This Phase 2a randomized clinical trial utilizing NTX-001 in nerve repair demonstrates its safety for use in the coaptation of nerves and shows a significant improvement in patient-reported pain scores and patient-reported functional outcome measures. Its potential to improve the care of patients with these devastating injuries using this novel technique is intriguing and holds promise for future clinical application,” said David M. Brogan, MD MSc, Associate Professor of Orthopedic Surgery, Washington University in St. Louis and Lead Author of the study. “We are excited about the results and are rapidly preparing to present these top-line results at an upcoming scientific conference, and we anticipate an End of Phase 2 meeting with the FDA in the near future to discuss late-phase development and the approval pathway,” said Evan Tzanis, Chief Operating Officer and EVP of R&D at Neuraptive Therapeutics, Inc. “We are thankful to the patients, investigators, and their staff for their participation and commitment to this study.” With the continued advancement of NTX-001, Neuraptive Therapeutics, Inc. remains at the forefront of developing novel solutions for a significant number of patients are affected by peripheral nerve injuries globally. About Neuraptive Therapeutics, Inc. Neuraptive Therapeutics, Inc. is dedicated to the innovation and development of medical products and therapeutics to repair and regenerate peripheral nerves. The company is focused on addressing the unmet medical needs of patients and physicians dealing with the complex challenges of nerve injuries. Notice Regarding Forward-Looking Statements This press release contains forward-looking statements subject to various risks and uncertainties. Actual results could materially differ from those anticipated in the forward-looking statements due to various factors. Neuraptive Therapeutics, Inc. disclaims any obligation to update the information contained in these forward-looking statements.