INmune Bio, the immunology company based in Boca Raton, Florida, announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on its Alzheimer's disease program. This development paves the way for INmune Bio to proceed with its Phase 2 study utilizing its XPro product candidate to treat patients with Alzheimer's disease and neuroinflammation.
The company is pleased to report that the study is progressing as planned, with the last patient expected to be enrolled by mid-2024. Subsequently, INmune Bio anticipates releasing top-line data approximately six months after the enrollment of the final patient.
The FDA had imposed the clinical hold in May 2022 to gather additional information about XPro. However, INmune Bio successfully continued recruiting participants at locations outside of the United States during this period.
With the Phase 2 program expected to be completed this year, INmune Bio looks forward to conducting an end-of-Phase II meeting with the FDA in early 2025. This meeting will serve to confirm plans for a global Phase 3 study.
