INmune Bio announces FDA alignment on phase 2b/3 registration pathway

INmune Bio (INMB) announced that it received the official minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA. The minutes confirm regulatory alignment on the Company’s proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer’s Disease. “The outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,” said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. “The FDA’s feedback on our enrichment-led design, primary endpoint, and integrated Phase 2b/3 structure validates our scientific and clinical strategy and provides a clearly defined regulatory path to advancing XPro1595 into a registration-intent program in early Alzheimer’s disease.”