By Ben Glickman


INmune Bio said that its study of a treatment for Alzheimer's disease would remain on full clinical hold despite previous issues being addressed.

The Boca Raton, Fla.-based immunology company said that the U.S. Food and Drug Administration had requested additional information on long-term potency of the treatment.

The company is currently on track to complete enrollment of its Phase 2 clinical trial of pegipanermin in treating early Alzheimer's disease in 2024.

INmune said the request came after a submission to the FDA "showed a possible increase in the long-term potency" of the treatment.

The company said that it would provide clarification to the FDA in response before the end of the year, which it believes will resolve remaining questions.

The company's trial is open in Australia, Canada, the U.K., Poland, France and Spain, and is expected to open soon in several other European countries.

INmune said the FDA was the only regulatory agency to put the trial on hold. The company's patient recruitment projections do not rely on any sites in the U.S.


Write to Ben Glickman at ben.glickman@wsj.com


(END) Dow Jones Newswires

12-18-23 1631ET