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# Hold Lifted on INmune Alzheimer’s Trial
- URL: https://www.fdaweb.com/hold-lifted-on-inmune-alzheimers-trial/
- Published: 2024-01-30T12:00:00.000Z
- Updated: 2026-09-14T14:21:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156250

FDA has lifted a 2022-imposed clinical hold against INmune Bio’s XPro (XPro1595; pegipanermin) and its Alzheimer’s disease clinical trial. “The Phase 2 trial is on track to enroll the last patient mid-2024,” the company says, adding that top line data is expected about six months after the last patient is enrolled.

“Our primary goal is to complete the Phase 2 program in 2024 followed by an end-of-Phase 2 meeting with the FDA in early 2025 to confirm our planned global Phase 3 trial that will include sites in the U.S., Canada, U.K., EU and Pacific rim,” INmune says.

XPro 1595 is described as a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF without affecting trans-membrane TNF or TNF receptors. The company says the hold was related to an agency request for additional chemistry manufacturing and controls information. While on clinical hold, the Phase 2 trial remained open in Australia and continued to enroll patients. “XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation,” the company says.