Neuraptive Therapeutics, Inc. Announces Achievement of Proof of Concept in The NEUROFUSE Study of NTX-001 for the Adjunct Treatment of Transected Peripheral Nerves

• The NEUROFUSE Study is an ongoing 48-week Multicenter, Randomized, evaluator-blinded, Phase 2a study in upper extremity nerve transections comparing NTX-001 adjunctive to standard of care (SOC) to SOC alone.
• In a planned interim analysis of the primary timepoint, NTX-001 demonstrated early and sustained improvement in function and symptoms compared to standard of care.
• The company plans to submit these top-line results for presentation at an upcoming scientific conference in 2024.
• The company plans to meet with the FDA in the first half of 2024 to discuss future late-phase development and the path to approval.

WAYNE, Pa.--(BUSINESS WIRE)--Neuraptive Therapeutics, Inc., a leader in nerve repair and regeneration, is pleased to announce a significant milestone in transforming the treatment paradigm for peripheral nerve injuries. The successful demonstration of proof of concept in the NEUROFUSE study of NTX-001 marks an unprecedented advancement in providing hope for faster and more complete functional recovery to individuals impacted by peripheral nerve transections.

Peripheral nerve injuries can have debilitating consequences, often leading to loss of sensory and motor functions. Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.

Key highlights from the NEUROFUSE Study:

The NEUROFUSE Study is a 48-week, Multicenter, Randomized, Controlled, Evaluator-Blinded Study comparing NTX-001 as an adjunct treatment to standard of care vs. standard of care alone. The study was to enroll 60 patients, and patients were randomized in a 1:1 ratio between treatments. The primary endpoints included safety (Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events) and the change from the baseline in the Michigan Hand Questionnaire (MHQ) Total score at 12 weeks. Additionally, secondary endpoints included the Numeric Pain Rating Scale (NPRS), multiple sensory assessments, measures of motor function, the Semmes-Weinstein Monofilament Test (SWMT), and Patient Global Impression of Change (PGIC).

Top-Line 12-Week Results:

Fifty-one patients were randomized and included in the Intent to Treat and Safety population. The primary endpoint of safety was met; NTX-001 demonstrated fewer treatment-emergent adverse Events (TEAE) and serious adverse events (SAE) for patients receiving NTX-001 vs. standard of care alone. For efficacy, the MHQ change at baseline in Total Score at 12 weeks demonstrated that NTX-001 treatment was numerically improved over SOC but did not reach statistical significance for this global function assessment. However, a statistically significant separation favoring NTX-001 was observed at 8 weeks. Several Secondary Endpoints showed statistically significant advantages favoring NTX-001, including NPRS and PGIC at 12 weeks. Sensory endpoints were consistent in demonstrating numerical advantages in favor of NTX-001 treatment.

“The NEUROFUSE Study of NTX-001 has yielded promising early clinical results consistent with preclinical studies,” said Evan Tzanis, Chief Operating Officer and EVP of R&D at Neuraptive Therapeutics, Inc. “These results suggest that NTX-001 may significantly improve outcomes as an adjunctive treatment to standard upper extremity primary nerve repairs, offering patients the possibility of faster and more complete restoration of functionality and clinically significant improvement in pain and quality of life. We wish to thank the patients, the investigators, and their staff for their participation, contributions to this study, and the advancement of science. We are excited to discuss these results with the Regulators to confirm the pathway to a confirmatory study and, ultimately, approval.”

“Neuraptive's vision is to significantly improve the peripheral nerve injury treatment landscape. These initial results represent a major step in realizing that vision," said Robert Radie, Chairman and CEO of Neuraptive Therapeutics, Inc. "We remain steadfast in our commitment to enhancing patients' lives and to create value for our stakeholders.”

Cutting-Edge Mechanism: NTX-001 operates through a unique mechanism of action. NTX-001 integrates a biophysical understanding of the severed axonal microenvironment and dynamics of PEG-fusion to repair axon membranes to restore measurable nerve conduction. Reestablishing axonal continuity addresses the underlying cause of nerve degeneration rather than relying on the body’s regenerative process.

Collaboration with Leading Experts: Neuraptive Therapeutics, Inc. has partnered with experts and researchers in peripheral nerve injuries. These collaborations have propelled the development of NTX-001, reinforcing our commitment to advancing the science of nerve repair and regeneration.

Late-phase confirmatory Clinical Trials on the Horizon: With the successful proof of concept, Neuraptive Therapeutics, Inc. is now preparing to initiate late-phase human clinical trials for NTX-001. This represents a pivotal step in our mission to deliver transformative treatments to patients.

For more information about Neuraptive Therapeutics, Inc., and our pioneering work in peripheral nerve injury treatments, please visit Neuraptive.com.

About NTX-001

NTX-001 is the only surgical technology that rapidly improves functional outcomes in patients with peripheral nerve injuries by preventing Wallerian degeneration after PEG-fusing severed axons using an optimized and specific treatment sequence in a controlled nerve isolation chamber.

About Neuraptive

Neuraptive Therapeutics, Inc. is a biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs of physicians and patients impacted by peripheral nerve injuries. The company is headquartered in Wayne, PA. For more information, see www.neuraptive.com.

This press release contains forward-looking statements that are subject to risks and uncertainties. Due to various factors, actual results may differ materially from those indicated in the forward-looking statements. The Company disclaims any obligation to update or revise forward-looking statements.