INmune Bio Inc. Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results

Reuters

30 Jun

<a href="https://laohu8.com/S/INMB">INmune Bio Inc</a>. Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results

INmune Bio Inc. has announced plans to file for Breakthrough Therapy Designation with the FDA following the results of their Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer's Disease. The trial demonstrated cognitive, behavioral, and biological benefits in a subset of patients with two or more biomarkers of inflammation. Additionally, INmune Bio intends to schedule an End-of-Phase 2 meeting with the FDA in Q4 2025 to chart the course for a pivotal trial aimed at supporting the approval of XPro™. The company will also engage with regulatory authorities in the UK, EU, and other regions in parallel. This strategic move marks a significant step forward in the development of XPro™ for treating early Alzheimer's Disease.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. INmune Bio Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9486507-en) on June 30, 2025, and is solely responsible for the information contained therein.

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Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/INMB\">INmune Bio Inc</a>. Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        INmune Bio Inc. has announced plans to file for Breakthrough Therapy Designation with the FDA following the results of their Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer's Disease. The trial demonstrated cognitive, behavioral, and biological benefits in a subset of patients with two or more biomarkers of inflammation. 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Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-06-30 19:30</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/INMB\">INmune Bio Inc</a>. Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        INmune Bio Inc. has announced plans to file for Breakthrough Therapy Designation with the FDA following the results of their Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer's Disease. The trial demonstrated cognitive, behavioral, and biological benefits in a subset of patients with two or more biomarkers of inflammation. Additionally, INmune Bio intends to schedule an End-of-Phase 2 meeting with the FDA in Q4 2025 to chart the course for a pivotal trial aimed at supporting the approval of XPro™. The company will also engage with regulatory authorities in the UK, EU, and other regions in parallel. 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Seeks Breakthrough Therapy Designation for XPro™ Following Promising Phase 2 Alzheimer's Trial Results\n    \n\n        INmune Bio Inc. has announced plans to file for Breakthrough Therapy Designation with the FDA following the results of their Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer's Disease. The trial demonstrated cognitive, behavioral, and biological benefits in a subset of patients with two or more biomarkers of inflammation. Additionally, INmune Bio intends to schedule an End-of-Phase 2 meeting with the FDA in Q4 2025 to chart the course for a pivotal trial aimed at supporting the approval of XPro™. The company will also engage with regulatory authorities in the UK, EU, and other regions in parallel. This strategic move marks a significant step forward in the development of XPro™ for treating early Alzheimer's Disease.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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