PHILADELPHIA–(BUSINESS WIRE)–Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.

FDA Fast Track is a program designed to facilitate and expedite the development and review of a new drugs that demonstrates the potential to address an unmet medical need in the treatment of a serious or life-threatening condition. The purpose of the program is to get important new therapies to the patients earlier than would be achieved through the standard approval process.

“We appreciate the FDA’s recognition of the serious and urgent need for improvements in nerve repair therapies,” said Evan Tzanis, Executive Vice President and Head of Research and Development of Neuraptive. “With no products currently available that help to restore nerve function quickly, NTX-001 offers a potentially significant improvement to the current standards of care. Fast Track designation provides several important advantages that could expedite the development of NTX-001.” In April, FDA cleared the company’s Investigational New Drug (IND) application for NTX-001.

“We are very pleased that NTX-001 has been granted Fast Track designation,” said Ivan Gergel, MD, Neuraptive’s Executive Chairman of the Board. “Not only does this make the program eligible for accelerated approval and priority review, but it also serves as an important validation that NTX-001 may fill a significant unmet medical need. We look forward to advancing this program into the clinic later this year.”

The company believes 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.

About FDA Fast Track Designation

Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstrated potential to address an unmet medical need. Fast Track helps new drugs advance through the FDA approval process more quickly to get them to the patients who need them, and addresses a broad range of serious conditions.

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings and interactions with the review team at the FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval as well as to discuss accelerated approval, the structure and content of an NDA, and other critical issues
• More frequent written communications from FDA about such things as the design of the proposed clinical trials and use of biomarkers
• Eligibility for Accelerated Approval and Priority Review if relevant criteria are met
• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the marketing application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA. (https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track)

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. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com.

About New Rhein Healthcare Investors

New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer’s disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein’s partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.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.