CHESTERBROOK, PA — Neuraptive Therapeutics, Inc. has announced that its investigational therapy, NTX-001, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is poised to expedite the development and review process of NTX-001, aiming to address critical needs for patients with peripheral nerve injuries.
NTX-001 showed promising outcomes in the Phase 2 NEUROFUSE study, and Neuraptive is preparing to initiate a pivotal Phase 3 trial in early 2025. This trial will be a single randomized, double-blind, placebo-controlled study evaluating the treatment’s efficacy and safety.
Evan L. Tzanis, COO and EVP of R&D at Neuraptive, emphasized the importance of this designation: “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.”
With the formal discussions for the Phase 3 study protocol underway, Neuraptive is advancing NTX-001 swiftly, with hopes of delivering transformative nerve repair therapy to patients. The company plans to release comprehensive results from the Phase 2 study soon and share insights at an upcoming scientific conference.
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