The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Neuraptive Therapeutics’ NTX-001 for the treatment of patients with peripheral nerve injury requiring repair.

The BTD status was awarded following the promising results from the Phase II NEUROFUSE study and subsequent discussions with the US regulator.

Neuraptive is preparing to initiate a Phase III programme for NTX-001 in early 2025.

The programme will include a randomised, double-blind, placebo-controlled trial to evaluate the safety and efficacy of NTX-001 in patients with peripheral nerve injuries.

The final study protocol for the prospective Phase III trial is under discussion with the regulator, building on the encouraging data observed after 24 weeks in the NEUROFUSE study.

Neuraptive anticipates that the complete set of results, encompassing the full 48 weeks of data, will be available soon.

Dedicated to advancing medical solutions for nerve repair and regeneration, Neuraptive Therapeutics continues to focus on the development of innovative products and therapeutics that can improve the lives of patients with peripheral nerve injuries.

Neuraptive Therapeutics chief operating officer and research and development executive vice-president Evan Tzanis stated: “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.

“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.”

In January 2024, the FDA granted orphan drug designation to NTX-001 for peripheral nerve injury repair.