INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease

Treatment with XPro was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients

INmune Bio announced results from its Phase 2 MINDFuL trial evaluating XPro, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population, predefined analyses demonstrated a cognitive benefit for XPro on the primary endpoint EMACC.

The MINDFuL trial enrolled 208 participants with early-stage AD to assess XPro’s potential in slowing cognitive decline. While the primary endpoint was not met in the mITT group, key changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated with XPro over patients treated with placebo. These results identify population of AD patients.

“These results highlight the potential of XPro,” stated RJ Tesi, MD, CEO of INmune Bio. “Our findings indicate that XPro may offer benefits to Alzheimer’s patients across all age groups, regardless of comorbidities, additional medications, or ApoE4 status. This evidence lays the foundation for advancing XPro as a promising treatment option for Alzheimer’s disease.”

CJ Barnum, PhD, VP of CNS Drug Development, added, “By targeting neuroinflammation, a key driver of Alzheimer’s disease progression, XPro offers a novel mechanism to potentially slow disease progression and cognitive symptoms for persons living with Alzheimer’s disease and inflammation. The continued development of this therapeutic, whether as a standalone treatment or in combination with other therapies, holds promise in addressing this critical and growing unmet medical need.”