INmune Bio, an immunology company based in Boca Raton, Florida, has announced that its study on a potential treatment for Alzheimer’s disease will continue to be on full clinical hold, despite addressing previous issues.
The U.S. Food and Drug Administration (FDA) has requested additional information regarding the long-term potency of the treatment. This request was made after the company submitted data that indicated a possible increase in the long-term potency of the treatment.
To address the FDA’s concerns, INmune Bio will provide clarification before the end of the year. The company believes that this additional information will resolve any remaining questions.
The Phase 2 clinical trial of pegipanermin, the potential treatment for early Alzheimer’s disease, is currently underway. The company aims to complete enrollment by 2024. The trial is open in several countries, including Australia, Canada, the U.K., Poland, France, and Spain, with plans to expand to other European countries in the near future.
It’s important to note that the FDA is the only regulatory agency that has put the trial on hold. Patient recruitment projections by INmune Bio do not rely on any sites within the United States.