INmune Bio announces FDA removal of clinical hold for Alzheimer disease program

INmune Bio received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted. The Phase II trial is on track to enroll the last patient mid-2024. Top line data is expected approximately six months after the last patient is enrolled. “We are pleased with the FDA’s response and will continue to work closely with the agency in anticipation of our Phase III AD program,” said RJ Tesi, CEO of INmune Bio. “Our primary goal is to complete the Phase II program in 2024 followed by an end-of-Phase II meeting with the FDA in early 2025 to confirm our planned global Phase III trial that will include sites in the U.S., Canada, U.K., E.U. and Pacific Rim.”