Inmune Bio Receives FDA Alignment on Alzheimer's Drug XPRO1595 Phase 2b/3 Trial Design

The U.S. Food and Drug Administration has aligned on the design of the pivotal Phase 2b/3 trial for Inmune Bio's (INM.-16) Alzheimer's disease candidate XPRO1595, according to a regulatory filing dated February 12, 2026. The agency's guidance confirms the endpoint and dosing schedule, with enrollment expected to begin in the first half of 2026. The trial will assess the drug's ability to slow cognitive decline in 1,200 patients with early-stage Alzheimer's disease. The FDA alignment reduces uncertainty and is a key step toward a potential 2028 regulatory filing. The decision follows positive preliminary data from a smaller Phase 2 study and strengthens the timeline for Inmune Bio's commercialization goals.