INmune Bio announces Alzheimer’s trial remains on hold

INmune Bio received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency. The request came following the most recent submission to the FDA that showed a possible increase in the long-term potency of XPro. The company will provide clarification to the FDA in a response before the end of the year that it believes will resolve the remaining questions. “We remain discussion with the FDA regarding the clinical hold,” said RJ Tesi, CEO of INmune Bio. “The hold will not impact our progress in completing the Phase II AD study on schedule, as our patient recruitment projections are solely reliant on sites outside of the US.” The trial is open in Australia, Canada, the United Kingdom, Poland, France, Spain and is expected to open soon in several additional EU countries. To date, the FDA remains the only regulatory agency to put the Phase II clinical trial on hold.