NurExone Announces Plan to Submit Pre-Investigational New Drug Meeting Request to U.S. Food and Drug Administration

November 02, 2022 8:00 AM EDT | Source: NurExone Biologic Inc.

  • The U.S. Food and Drug Administration (FDA) informed NurExone that it is at the appropriate stage of its product development for a pre-Investigational New Drug (pre-IND) meeting
  • A pre-IND meeting could potentially shorten the regulatory timeline for the launch of NurExone's ExoTherapy into the U.S. market.

Calgary, Alberta--(Newsfile Corp. - November 2, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, is pleased to announce the Company's plan to submit a pre-IND meeting request to the FDA.

Prior to submission of a New Investigational Drug (IND) application, in September 2022, the Company submitted a request for an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting, which is an informal, non-binding meeting that is offered by the U.S. FDA to companies at an early stage in product development. In an official response to the Company's INTERACT meeting request, the FDA informed NurExone that the Company is beyond the stage of participating in this informal meeting and is instead appropriate for the next type of formal meeting, known as a Pre-IND meeting in connection with the development of ExoPTEN, NurExone's first ExoTherapy product.

A Pre-IND meeting provides applicants with information towards preparation of complete IND applications, reducing the risk of a clinical hold and outlining main guidelines for the applicant to plan and prepare its clinical studies for its product. As a result, a pre-IND meeting could potentially reduce the length of time needed by the Company to gain regulatory approval for launching its product in the U.S. market.

Dr. Lior Shaltiel, CEO of NurExone, added, "Proceeding directly to a Pre-IND meeting could save us several months and expedite the process of obtaining FDA approval for our ExoTherapy product. I believe that an accelerated regulatory timeline will allow us, subject to product approval, to gain a first-mover advantage in launching our unique exosome-based drug platform for treating traumatic spinal cord injuries in the United States."

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. NurExone is translating the treatment to humans, and the company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

For investors:
Investor Relations
IR@nurexone.com

+1 905-347-5569

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company's future plans and intellectual property, the scientific and development activities to be carried out by the company, regulatory activities and timelines (including the scheduling and convening a pre-IND meeting, regulatory approvals and product launch) future potential manufacturing and marketing activities and the treatment of certain conditions. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the Company's early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company's intellectual property and dependence on the Company's strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/142693

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