FDA Lifts Clinical Hold on INmune Bio Alzheimer's Program

By Colin Kellaher

INmune Bio on Tuesday said the U.S. Food and Drug Administration has lifted the full clinical hold on the immunology company's Alzheimer's disease program.

The Boca Raton, Fla., company said a Phase 2 study using its XPro product candidate to treat patients with Alzheimer's Disease with neuroinflammation is on track to enroll its last patient in mid-2024, adding that it expects top-line data about six months after the last patient is enrolled.

The FDA implemented the clinical hold in May 2022 as the agency sought more information about XPro, but INmune has been able to continue study enrollment at sites outside the U.S.

INmune said it aims to complete the Phase 2 program this year and to hold an end-of-Phase II meeting with the FDA in early 2025 to confirm plans for a global Phase 3 study.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

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