INmune Bio Inc. announced that it has received official feedback from the U.S. Food and Drug Administration (FDA) confirming regulatory alignment on the company’s proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer’s disease. The FDA agreed with INmune Bio’s enrichment-led trial design and confirmed the use of the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) as the sole primary endpoint for the registrational Phase 3 portion of the study. INmune Bio is incorporating the FDA’s feedback into its final Phase 2b/3 protocol and plans to submit the protocol for agency review. The company stated that additional updates on study timelines will be provided as the protocol is finalized. Results from the Phase 2 MINDFuL trial, which informed the new study design, have already been presented.

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