Neuraptive Therapeutics Receives FDA Breakthrough Therapy Designation for NTX-001 and Provides Update on the Advancements of NTX-001 for the Treatment of Peripheral Nerve Injury Requiring Repair

– Breakthrough Therapy designation for NTX-001 granted by FDA

– Preparation is underway for the Phase 3 program to begin in early 2025

CHESTERBROOK, Pa.--(BUSINESS WIRE)--Neuraptive Therapeutics, Inc. today announced that NTX-001 has been granted Breakthrough Therapy Designation, thus providing the potential for accelerated development for patients with peripheral nerve injury requiring repair. This designation follows the results from the Phase 2 NEUROFUSE study and several interactions with the FDA. NTX-001 has the potential to be a groundbreaking therapy in the field of nerve repair.

Neuraptive is preparing to launch a Phase 3 pivotal program for NTX-001 in early 2025. The program will consist of a single randomized, double-blind, placebo-controlled study assessing the efficacy and safety of NTX-001 in patients with peripheral nerve injury requiring repair. The final protocol for this single Phase 3 study is currently being discussed with the FDA. This follows the promising results from the Phase 2 NEUROFUSE study after 24 weeks. Neuraptive anticipates the full results, including all 48 weeks of data, to be available in the coming weeks and will look to share the results at an upcoming scientific conference.

“The FDA’s Breakthrough Therapy designation for NTX-001 is a major step forward in our mission to provide an innovative treatment for patients suffering from peripheral nerve injuries requiring repair,” said Evan L. Tzanis, COO and EVP of R&D at Neuraptive Therapeutics. “We are eager to continue working closely with the FDA to ensure NTX-001 reaches patients as quickly as possible and to deliver a transformative therapy in the field of nerve repair. We are grateful to the patients, investigators, and our partners who have remained committed to advancing NTX-001.”

With the continued advancement of NTX-001, Neuraptive Therapeutics, Inc., remains at the forefront of developing novel solutions for a significant number of patients 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.