INmune to Provide More Manufacturing Data to FDA on Alzheimer's NDA

  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced that on May 20, 2022, the Company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) requesting additional information around Chemistry Manufacturing and Controls (CMC) of the newly manufactured XPro1595 (XPro™).  As part of the communication, the Agency placed the Company’s Investigational New Drug (IND) application to initiate its Phase 2 clinical trial of XPro™ in patients with Alzheimer’s Disease (AD) in the U.S. on clinical hold.  The FDA indicated they will provide an official clinical hold letter to INmune in approximately 30 days.  INmune plans to provide additional updates pending discussion with the FDA.  The Phase 2 trial of XPro™ remains open in Australia and continues to enroll patients.

https://finance.yahoo.com/news/inmune-bio-inc-additional-manufacturing-200000526.html