Neuraptive Therapeutics Announces Presentation of Phase 2 Topline Interim Results for NTX-001 at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting

- Interim 24-week data from the NEUROFUSE study highlights the safety and efficacy of NTX-001 for peripheral nerve injuries.

Neuraptive Therapeutics Inc., a leading biopharmaceutical company focused on novel treatments for peripheral nerve injuries, today announced that interim topline results from its ongoing Phase 2 NEUROFUSE Study will be presented at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting, held September 19-21 in Minneapolis, MN. The presentation, titled Safety and Efficacy of NTX-001 in the Treatment of Acute Single Transected Peripheral Nerve Injuries: A Phase 2 Randomized Controlled Trial, was awarded a Top 10 Best Paper designation and will be presented by Dr. David Brogan of Washington University during the scientific paper session on Thursday, September 19.

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David M. Brogan, MD, MSc, Assistant Professor, Orthopaedic Surgery, Division of Hand and Microsurgery, Washington University in St. Louis (Photo: Business Wire)

The presentation will highlight interim findings from the 24-week analysis of the NEUROFUSE study, which evaluates the safety and efficacy of NTX-001 in patients suffering from acute, single-transected upper extremity peripheral nerve injuries. NTX-001 is a drug-device combination designed to improve the speed and durability of functional recovery when used alongside standard surgical repair. These results represent an important milestone in the continued development of NTX-001 as a novel treatment option for peripheral nerve injuries.

Key interim findings at 24 weeks include:

• NTX-001 demonstrated a significant improvement in MHQ total scores at 8- and 24 weeks post-operation compared to standard of care alone
• There were no safety findings associated with the use of NTX-001
• At all-time points, patients treated with NTX-001 demonstrated significantly reduced post-operative pain compared with SOC alone.

These results underscore the potential of NTX-001 to enhance functional recovery in peripheral nerve injury patients and support further development.

According to Dr. Brogan, lead author on the paper and primary investigator at Washington University in St. Louis, “traumatic peripheral nerve transections are an unsolved problem in hand and upper extremity surgery, and the potential use of PEG fusion to meet this challenge has gained considerable interest among clinicians who deal with these devastating injuries. This data demonstrating improvement in pain and patient-reported outcomes is an exciting first step in addressing the needs of these patients.”

"We are pleased to share these promising interim results from our Phase 2 trial of NTX-001 at such an important Scientific conference, and look forward to sharing full study results at future scientific conferences," said Evan Tzanis, Chief Operating Officer and Head of R&D at Neuraptive Therapeutics, Inc. "We are immensely grateful to all those involved in this study, including the investigators, supporting staff at the clinical sites, our team, and most importantly, the patients who participated in the study," said Tzanis.

About ASSH

The American Society for Surgery of the Hand is the oldest medical society dedicated to the hand and upper extremity. Its mission is to advance the science and practice of hand and upper extremity surgery through education, research, and advocacy on behalf of patients and practitioners. For more information, please visit www.assh.org.

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.

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