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INmune Bio Inc. (INMB) on Monday said that its experimental drug XPro did not show any effects in the intent-to-treat population in a mid-stage study evaluating its effectiveness in early Alzheimer’s Disease (AD) with biomarkers of inflammation.
INmune’s stock fell about 59% in morning trade at the time of writing.
The trial enrolled 208 participants with early-stage Alzheimer’s to asses the drug’s potential in slowing cognitive decline by tackling neuroinflammation.
The primary endpoint of the study was a change in cognition over 6 months on the Early Mild Alzheimer’s Cognitive Composite (EMACC). EMACC is a tool used in clinical trials and research to assess cognitive changes in individuals with early or mild Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).
The primary endpoint was not met in the intent-to-treat population.
However, changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of 100 early Alzheimer's patients with inflammation biomarkers who were treated with XPro, compared to patients treated with placebo, the company said.
CEO RJ Tesi said that the findings lay the foundation for advancing XPro as a “promising treatment option” for Alzheimer’s.
XPro treatment was safe and well-tolerated, the company added.
INmune now intends to schedule an end-of-mid-stage meeting with the U.S. Food and Drug Administration (FDA) in the last quarter of 2025 to define the path forward for a pivotal trial to support XPro approval in early Alzheimer’s.
Despite the drop in INMune stock during Monday’s trading session, retail sentiment around the stock is trending in the ‘extremely bullish’ territory on Stocktwits.
INMB stock is down by about 53% this year and by about 74% over the past 12 months.
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