NurExone Biologic Inc. announced 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 the company's 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 fourth quarter, 2024, and expects to initiate Phase 1/2 human clinical studies in 2025. 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.