Neuraptive Therapeutics Announces FDA Clearance of a Second IND Application for NTX-001 in the Prevention of Postoperative Facial Paralysis and Plans to Initiate a Phase 2 Clinical Study Later This Year

• NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves.
• Neuraptive plans to conduct a Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.

PHILADELPHIA--(BUSINESS WIRE)--Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs in the treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has cleared Neuraptive’s Investigational New Drug (IND) application for NTX-001 in Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.

"We are pleased to have received FDA clearance for the company’s second IND for NTX-001, and we are excited at the potential to address this significant unmet medical need," said Robert Radie, Chairman, and CEO.

“Neuraptive’s R&D team has been working with a very distinguished group of key opinion leaders led by Dr. Michael Klebuc, to design the study,” said Evan Tzanis, EVP and Head of Research and Development. “The potential to avoid the dysfunctions associated with these surgical procedures may prevent the significant physical and psycho-social impact that these patients experience in their recovery. We hope to initiate this study later this year.”

Dr. Klebuc is the director of the Center for Facial Paralysis Surgery and Functional Restoration at the Methodist Hospital in Houston, Texas. Dr. Klebuc added, “We have put together a multi-centered group of physician-scientists who are eager to evaluate this new technology. The ability to fuse injured nerves and restore some degree of immediate function would be an incredible advancement in the treatment of facial nerve injuries. It would truly create a paradigm shift in the field.”

The current surgical standard of care includes preservation and immediate microsurgical repair of the facial nerve when damaged during a surgical procedure such as parotidectomy. Despite current surgical techniques, it is not unusual for the nerve to be damaged, causing facial nerve weakness and paralysis even when nerves are immediately repaired due to Wallerian degeneration. Up to 64% of patients will suffer significant complications leading to 6 months or more of severe dysfunction and even permanent dysfunction. At present, there are no other approved agents to improve standard surgical practice for this condition.

About Neuraptive Therapeutics

Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures and has received Fast Track Designation from the FDA. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. The company is headquartered in Philadelphia, PA. For more information, see www.neuraptive.com.

Cautionary Note on Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.