Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 557

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 4
Chunk 557
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 a blinded randomized trial to test if treatment of early AD patients with neuroinflammation with XPro will affect cognitive
decline. The Phase II trial in early ADi has six important elements. Two hundred and one patients are being enrolled in a 2:1 ratio (XPro
vs placebo). The patients will receive 1mg/kg/week as a subcutaneous injection for six months. An enrichment strategy identical to the
successful strategy used in the Phase I trial will be used to ensure patients have neuroinflammation. Patients will need to have one or
more enrichment criteria: elevated blood level of at least one of C-reactive protein, hemoglobin A1c, erythrocyte sedimentation and at
least one allele of ApoE4. The primary end-point will be Early/mild Alzheimer’s Cognitive Composite (“EMACC”), a validated
cognitive measure that is more sensitive than traditional end-points used in many studies of patients with early AD. The AD program is
open in Australia, Canada, the United Kingdom, France, Germany, Spain, Czech Republic and Slovakia.

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Full enrollment in the Phase
II AD trial occurred in late 2024 with 208 patients enrolled. Topline data of EMACC is expected to be reported in June followed by secondary
end-points which include blood biomarker, neuroimaging and additional neuropsychiatric end-points which should be available 2-3 months
after top line data. Finally, several months after all the data are analyzed, the Company plans an end-of-phase II meeting with the FDA
to finalize plans for the pivotal Phase III trial. XPro for treatment of AD may be eligible for one or both accelerated approval pathways.
We expect to be eligible for Break Through status after completion of the Phase II in 2025.

Effective therapy for TRD
is a large unmet need. Twenty percent of patients with a Major Depressive Disorder have TRD. Once third of TRD patients have peripheral
biomarkers to inflammation (elevated CRP). This is a large patient population. The role of TNF and anti-TNF therapeutics was explored
in a small open label clinical trial by Prof. Andrew Miller, MD of Emory University demonstrated the patients have elevated TNF levels
and treatment with infliximab treated their depression (Miller, 2011). The Company has a $2.0M USD award from the National Institute of
Mental Health (“NIMH”) to treat TRD with