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

• 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.

Excerpt from the Press Release:

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.

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.

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