PA-NEURAPTIVE
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: https://www.businesswire.com/news/home/20240222942067/en/
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240222942067/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
CA-ANDERSEN-GLOBAL27.7.2024 11:39:35 CEST | Pressemeddelelse
Andersen Global tilføjer værdiansættelseskapacitet i Bulgarien
MI-LINEAGE26.7.2024 23:20:27 CEST | Press release
Lineage Announces Closing of Initial Public Offering
TN-LEDGER26.7.2024 17:16:33 CEST | Press release
Introducing LEDGER FLEX — Easy, Secure Self-Custody, Free From Compromise
CA-LAMBDATEST26.7.2024 17:01:33 CEST | Press release
LambdaTest Unveils Live Inspect for Enhanced App Automation Testing
RADICO-KHAITAN26.7.2024 15:05:31 CEST | Press release
Radico Khaitan comes onboard as the Official Partner for the first India House at The Paris 2024 Olympics
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom