Neuraptive Therapeutics, Inc. Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair
Excerpt from the Press Release:
Neuraptive Therapeutics, Inc., a biotechnology company focused on developing novel therapies to improve outcomes in peripheral nerve injuries (PNI), today announced the first patient has been enrolled in its phase 3 clinical trial using NTX-001 in peripheral nerve injuries due to trauma.
The phase 3 study is a multicenter, randomized, subject and evaluator blinded, controlled study evaluating the safety and efficacy of NTX-001 compared to standard of care (neurorrhaphy) in the treatment of upper extremity transected nerves requiring surgical repair. The study is expected to enroll approximately 110 patients across approximately 24 clinical sites within the US. Subjects will be randomized in equal numbers to receive either standard of care or NTX-001 as an adjunct to standard of care.
“Enrolling the first patient in our phase 3 trial marks a major milestone for Neuraptive and NTX-001 for patients who have sustained traumatic injuries requiring surgical repair. We believe NTX-001 has the potential to set a new standard of care to address a significant unmet need, and this is another important step forward toward FDA approval,” stated Seth Schulman, MD, Chief Medical Officer of Neuraptive.
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