INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease

Core Insights - The FDA has provided regulatory clarity on INmune Bio's integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease, confirming CDR-SB as the sole primary endpoint for registrational development [1][2][5] FDA Alignment Highlights - The FDA's feedback validates the enrichment-led design and primary endpoint, supporting the scientific and clinical strategy of the company [2][5] - The Phase 2b study will include approximately 300 participants over a nine-month evaluation period, utilizing the Early Mild Alzheimer's Cognitive Composite (EMACC) and plasma p-tau-217 as key measures [4][5] - CDR-SB will serve as the sole primary efficacy endpoint for the Phase 3 segment, aligning with its established role in Alzheimer's therapies [5][6] Integrated Phase 2b/3 Framework - The FDA indicated no objection to the integrated Phase 2b/3 design under a single master protocol, with the full program expected to enroll around 1,000 participants [5] - The Phase 3 portion will evaluate XPro1595 over an 18-month period [5] - An exploratory cohort of non-enriched early Alzheimer's patients will be included to assess broader effects, comprising approximately 20% of total enrollment [5] XPro™ Overview - XPro™ is a next-generation TNF inhibitor that selectively neutralizes soluble TNF, potentially reducing neuroinflammation and improving cognitive function in neurological diseases [8] Company Background - INmune Bio Inc. is a late-stage clinical biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms including XPro™ [9]