NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone’s ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year with the goal of initiating Phase 1/2 clinical trials in 2025. In July 2022, the company said that it had contracted with Polyrizon for development of an intranasal formulation of exosomes loaded with modified siRNA sequences for the treatment of traumatic spinal cord injuries.
According to NurExone, the agency indicated in a written response that the company would not need to perform large-scale animal testing as part of its toxicity studies. The company also said that the letter contained “clear and valuable guidance” regarding chemistry manufacturing and controls.
NurExone CEO Lior Shaltiel commented, “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. This meeting is part of our continued commitment to advance our FDA regulatory approval strategy to launch ExoPTEN into the US market, where we see a high demand for acute spinal cord injury treatments.”
Read the NurExone press release.
