FDA meeting minutes suggest INmune Bio’s late-stage Alzheimer’s trial design is on track.
Shares of INmune Bio, Inc (INMB) rose over 6% in pre-market trading on Thursday, after the company said it has received official U.S. Food and Drug Administration (FDA) meeting minutes confirming regulatory alignment on its integrated Phase 2b/3 development plan for XPro1595, a potential therapy for early Alzheimer’s disease.
The FDA supported INmune Bio’s precision medicine strategy, which uses an enrichment-led trial design to identify patients whose inflammatory biomarker profiles are closely tied to soluble TNF signalling, the treatment’s biological target.
The agency’s assessment was based on the company’s Phase 2 data package, which included cognitive and biomarker findings from the selected patient population. The Phase 2b portion will feature a nine-month evaluation period to build the clinical foundation for a subsequent Phase 3 study, the company said.
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