Neuraptive Therapeutics, Inc. has announced that its therapy NTX-001 has received Breakthrough Therapy Designation from the FDA, which could accelerate its development for patients with peripheral nerve injuries that need repair. This designation is based on promising results from the Phase 2 NEUROFUSE study and discussions with the FDA. NTX-001 could potentially revolutionize nerve repair treatment.
Neuraptive Therapeutics is set to launch a Phase 3 pivotal study for NTX-001 in early 2025. This study will be a randomized, double-blind, placebo-controlled trial designed to evaluate NTX-001’s efficacy and safety in patients with peripheral nerve injuries requiring repair. The final study protocol is being discussed with the FDA. This follows promising 24-week results from the Phase 2 NEUROFUSE study, with full 48-week data expected soon and slated for presentation at a forthcoming scientific conference.
Evan L. Tzanis, COO and EVP of R&D at Neuraptive, commented, “The FDA’s Breakthrough Therapy designation for NTX-001 is a significant milestone in our mission to offer innovative treatments for peripheral nerve injuries. We look forward to working closely with the FDA to expedite NTX-001’s availability and are thankful for the continued support of patients, investigators, and partners.”
Neuraptive Therapeutics remains dedicated to advancing novel solutions for peripheral nerve injuries, addressing critical needs in the global patient population.
About Neuraptive Therapeutics, Inc.
Neuraptive Therapeutics is focused on developing innovative medical products and therapeutics for the repair and regeneration of peripheral nerves, aiming to address unmet needs in the treatment of nerve injuries.
