The FDA’s response indicated that the planned toxicity study strategy is acceptable under FDA guidelines and large-scale animal studies will not be required.
The completed Pre-IND meeting with the FDA is expected to expedite NurExone’s regulatory process to initiate Phase 1/2 human clinical studies in 2025.
TORONTO and HAIFA, Israel, Sept. 13, 2023 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”), a biopharmaceutical company developing biologically-guided exosome therapy (“ExoTherapy”) for patients with traumatic spinal cord injuries, is pleased to announce that the Company has completed a Pre-Investigational New Drug (“Pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) in connection with the manufacturing, preclinical and clinical development plan of ExoPTEN, NurExone’s first ExoTherapy product, after receiving a written response from the FDA on August 29, 2023.
A Pre-IND meeting offers open communication between applicants and the FDA, enabling the applicants to receive information regarding the preparation of an IND application and guidance for the clinical studies of the Company’s ExoPTEN drug. The FDA provided clear and valuable guidance on the chemistry manufacturing and controls and agreed that our proposed ExoPTEN release testing strategy would be expected to adequately control for safety of the ExoPTEN product for use in the planned first-in-human clinical trial. The FDA’s response to the Company indicated that the planned toxicity study strategy is acceptable under FDA guidelines and large-scale animal studies will not be required. Based on the FDA’s feedback, the Company plans to submit an IND application regarding the development of ExoPTEN by Q4, 2024, and expects to initiate Phase 1/2 human clinical studies in 2025.
“We are pleased to have completed a Pre-IND meeting with the FDA in connection with the development of ExoPTEN and are optimistic that this will help expedite our progress to the clinical stage,” said Dr. Lior Shaltiel, CEO of NurExone. “This meeting is part of our continued commitment to advance our FDA regulatory approval strategy to launch ExoPTEN into the U.S. market, where we see a high demand for acute spinal cord injury treatments.”
ExoPTEN is being developed to be a minimally invasive ExoTherapy for spinal cord injuries administrated intranasally and yielding neuron regeneration and rewiring in traumatically damaged spinal cords. The drug is being developed using NurExone’s proprietary ExoTherapy platform for producing and loading exosomes with pharmaceutical cargo targeting central nervous system injuries.
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 more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Email: [email protected]
Phone: +1 905-347-5569
Email: [email protected]
This press release contains certain “forward-looking statements”, that reflect the Company’s current expectations and projections about its future results. 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. Forward-looking statements in this press release include, but are not limited to, statements relating to the Company’s ExoTherapy drug, ExoPTEN, the planned toxicity study strategy with the FDA, potential first-in-human clinical trial for ExoPTEN, the completion of an IND application regarding the development of ExoPTEN, and the potential launch of a product into the U.S. market upon completion of applicable regulatory phases. These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof.
In developing the forward-looking statements in this press release, we have applied several material assumptions, including our ability to retain key personnel, our ability to continue investing in research and development, our ability to secure available funding and to continue as a going concern, the general business and economic conditions of the industries and countries in which we operate, our ability to execute on our business strategy, that there will be certain amount of demand for the Company’s potential product, inflation will remain stable, and that the results of our studies reflect results that can be extrapolated.
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, dependence on the Company’s strategic partners and the risks discussed under the heading “Risk Factors” on pages 29 to 36 of the Company’s Annual Information Form dated March 30, 2023, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. 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.
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