Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain

INmune Bio Inc. INMB stock is trading lower on Monday, with a session volume of 23.2 million, compared to the average volume of 1.45 million, as per data from Benzinga Pro.

The company announced results from its Phase 2 MINDFuL trial evaluating XPro, a selective soluble TNF inhibitor, in early Alzheimer’s Disease with biomarkers of inflammation.

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Despite showing no effects in the modified intent-to-treat population (mITT, n=200), predefined analyses demonstrated a cognitive benefit for XPro over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer’s patients with two or more biomarkers of inflammation at baseline (n=100).

The MINDFuL trial enrolled 208 participants.

The primary endpoint was the change in cognition over 6 months as measured by the Early Mild Alzheimer’s Cognitive Composite (EMACC), a cognitive assessment specifically designed to measure change in early AD patients.

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.

Key Findings in the Amyloid positive Early AD participants with two or more biomarkers of inflammation (N=100):

A clinical benefit of XPro over placebo was observed on the primary endpoint EMACC (effect size: 0.27) and the secondary endpoint Neuropsychiatric Inventory (effect size: -0.24).
A biological benefit of XPro over placebo was observed in blood levels of pTau217 (effect size: -0.20), the gold standard measure of AD pathology in the blood.
XPro treatment was safe and well tolerated, without any occurrences of ARIA-E or ARIA-H.
The study demonstrates that it is possible to safely target neuroinflammation in patients where neuroinflammation is a driver of AD pathology.

Additional analyses are underway and will be presented at AAIC in July.

Based on the totality of the data, the company intends to:

File for Breakthrough Therapy Designation with the FDA.
Schedule an End-of-Phase 2 meeting with the FDA in Q4 2025 to define the path for a pivotal trial to support XPro approval in early AD.

On Friday, INmune Bio announced a registered direct offering of 3 million shares at $6.30 per share, with approximately $19 million in gross proceeds.

The company intends to use the net proceeds for working capital and general corporate purposes.

Price Action: INMB stock is down 59% at $2.14 at the last check on Monday.

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