WAYNE, PA — Neuraptive Therapeutics, Inc. has unveiled compelling 24-week data from its ongoing NEUROFUSE study on NTX-001, bolstering the product’s status after the positive proof of concept results based on the 12-week data released in January 2024.
The latest findings from this multicenter, randomized, evaluator-blinded, Phase 2a study highlight NTX-001’s continued safety and efficacy as an adjunct treatment for transected peripheral nerves. At the 24-week milestone, NTX-001 continues to show a promising safety profile, with fewer treatment-emergent adverse events than the standard of care.
On the effectiveness front, NTX-001 demonstrated a statistically significant enhancement in hand function and symptomatology, as measured by the Michigan Hand Questionnaire (MHQ), compared to the standard of care alone. Clinically and statistically significant changes were observed at eight and 24-week intervals. Secondary endpoints, including the Numerical Pain Rating Scale, also showed statistically significant improvements favoring NTX-001 at the 24-week mark. These results validate the early clinical response reported at the 12-week interim point, showing consistent, supportive trends across multiple secondary endpoints, including various assessments of sensory recovery.
“Current techniques for repairing traumatic peripheral nerve injuries often yield disappointing functional outcomes with the potential for significant neuropathic pain,” said David M. Brogan, MD MSc, Associate Professor of Orthopedic Surgery, Washington University in St. Louis, and Lead Author of the study. He added that the Phase 2a randomized clinical trial using 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.”
Brogan emphasized the potential of NTX-001 to enhance care for patients with devastating injuries using this novel technique. He described the findings as “intriguing” and suggested that they hold promise for future clinical application.
Evan Tzanis, Chief Operating Officer and EVP of R&D at Neuraptive Therapeutics, Inc., echoed Brogan’s excitement about the results. “We 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,” Tzanis said. He expressed gratitude to the patients, investigators, and their staff for their participation and commitment to the study.
These promising results from the NEUROFUSE Study mark a significant milestone for Neuraptive Therapeutics, suggesting that NTX-001 could potentially revolutionize the treatment of transected peripheral nerves. As the company prepares to share these findings with the broader scientific community and engage with the FDA on future development, industry watchers will undoubtedly keep a close eye on the progress of NTX-001.
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