INmune Bio receives FDA Fast Track designation for XPro1595 in early Alzheimer’s disease, advancing its neuroinflammation-focused precision medicine program into adaptive Phase 2b/3 development.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
INmune Bio announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro1595 (pegipanermin), the company’s first-in-class selective soluble tumor necrosis factor (sTNF) inhibitor, for the treatment of early Alzheimer’s disease. The designation covers patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia, representing a large and growing patient population.
XPro1595 selectively neutralizes soluble TNF, a pro-inflammatory cytokine believed to play a central role in neuroinflammation and disease progression in Alzheimer’s disease. Unlike conventional TNF inhibitors, XPro1595 is designed to target harmful inflammatory signaling while preserving transmembrane TNF activity and its receptors, which support normal immune and neurological functions.
Growing evidence suggests that brain inflammation acts as an independent early driver of cognitive decline in Alzheimer’s disease, yet no approved therapy specifically targets these inflammatory pathways. By selectively inhibiting sTNF, XPro1595 aims to reduce neuroinflammation while maintaining protective immune responses.
David Moss, Chief Executive Officer of INmune Bio, described the Fast Track designation as a transformative milestone for the company’s Alzheimer’s disease program, emphasizing the growing need for therapies addressing inflammation-driven disease biology beyond amyloid-focused approaches.
The designation follows the company’s previously reported End-of-Phase 2 alignment discussions with the FDA regarding its integrated Phase 2b/3 adaptive registrational strategy. The planned precision-medicine program is expected to enroll patients with biologically confirmed early Alzheimer’s disease who also demonstrate elevated inflammatory biomarkers linked to accelerated disease progression.
The seamless adaptive study is designed to evaluate safety, biomarker response, imaging outcomes, and preliminary efficacy before potential expansion into Phase 3 development. According to the company, the Phase 2b portion is expected to use EMACC and plasma pTau217 as decision-gating endpoints, while the Phase 3 portion is expected to evaluate clinical outcomes including CDR-SB.
INmune Bio stated that findings from the Phase 2 MINDFuL trial (NCT05318976), including encouraging biomarker and neuroimaging results alongside a favorable safety profile, support continued advancement of XPro1595 into later-stage development.
Sharon Cohen MINDFuL trial investigator noted that many patients continue to experience disease progression despite recent treatment advances, highlighting neuroinflammation as a mechanistically distinct therapeutic target in early Alzheimer’s disease.
According to the Alzheimer’s Association 2026 Facts and Figures report referenced by the company, approximately 7.4 million Americans aged 65 years and older are living with Alzheimer’s dementia, while nearly 15 million individuals are affected by mild cognitive impairment, underscoring the importance of early therapeutic intervention.
Reference
INmune Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer’s Disease
About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.