Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 33

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 33
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, changes that contribute to improved synaptic function.

The successful completion
of the Phase I trial in AD has informed the design of a blinded randomized, placebo-controlled Phase II trial in patients with early ADi.
Early ADi includes patients with AD and MCI who have at least one biomarker of inflammation (ADi and MCI respectively).
The early ADi trial is 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 the United States, Australia, Canada, the United Kingdom, France, Germany, Spain, Czech Republic and Slovakia. All
patients will be offered to stay on therapy for at least 12 months in an extension trial. Clinical and biomarker data will be collected
during the extension trial.

There are at least 4 clinical
milestones associated with the Phase II trial in AD. Enrollment of 201 patients in the Phase II AD trial should be complete by mid-year.
Six months after the last patient is enrolled, top line cognition data with EMACC will be available. Secondary end-points which include
blood biomarker, neuroimaging and additional neuropsychiatric end-points will be available after data base lock 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. The Company plans to apply for an accelerated pathway during 2024. XPro for treatment of AD may be eligible
for one or both accelerated approval pathways. The Company plans to submit of Fast Track status in 2024.