INmune Bio Completes Phase 2 Alzheimer's Enrollment

Boca Raton, Florida, Sept. 30, 2024 – INmune Bio Inc., a clinical-stage biotechnology firm specializing in inflammation and immunology, has announced the conclusion of patient enrollment for its Phase 2 clinical trial targeting Alzheimer's Disease (AD). The trial, known as AD02, focuses on individuals with Early AD and biomarkers indicating high levels of neuroinflammation. The company confirmed the completion of new patient enrollment on September 27, after determining that the number of patients in the screening phase was sufficient to reach the trial's target of 201 participants. The participants currently undergoing screening will still be eligible to join the study, potentially leading to a slight over-enrollment.

CJ Barnum, PhD, Vice President of CNS Drug Development and the leader of the AD02 trial, expressed that this milestone is significant for INmune Bio, its partners, and the trial participants. Barnum highlighted the exceptional commitment exhibited by everyone involved in the study. An enrollment exceeding the 201-patient target is expected to enhance the power of the trial, and the team is eagerly anticipating the final results.

The AD02 trial is an international, randomized, and blinded Phase 2 study aimed at patients with Early AD, which includes both mild cognitive impairment and mild AD. Participants must present at least one of four inflammatory biomarkers: elevated CRP, HgbA1c, ESR, or the ApoE4 allele. The trial involves administering either XPro™ or a placebo in a 2:1 ratio over a six-month period. Key cognitive endpoints will be assessed using EMACC and CDR. XPro™ is delivered as a weekly subcutaneous injection.

Neuroinflammation, which refers to chronic inflammation in the brain, is a natural part of aging known as inflammaging. Aging, behavioral, and genetic factors contribute to increased neuroinflammation, which is recognized as a significant factor in the development and progression of neurodegenerative diseases, including Alzheimer's. Neuroinflammation leads to nerve cell death and synaptic dysfunction, resulting in cognitive decline. Blocking neuroinflammation with XPro™ has shown promise in decreasing neurodegeneration, improving synaptic function, and promoting remyelination in animal models. These effects are currently being tested in the Phase 2 trial.

XPro™ (XPro1595 or pegipanermin) is an innovative inhibitor of tumor necrosis factor (TNF), specifically targeting soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors. By selectively neutralizing sTNF, a pro-inflammatory cytokine involved in neuroinflammation, XPro™ holds potential benefits for patients with neurological diseases.

INmune Bio Inc. is a publicly traded biotechnology company focused on developing therapies that target the innate immune system to combat disease. The company’s product platforms include the Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which selectively neutralizes soluble TNF. Products from this platform are in clinical trials to treat conditions like cancer (INB03™), Early Alzheimer’s disease, and treatment-resistant depression (XPro™). Another platform, the Natural Killer Cell Priming Platform, includes INKmune™, which primes a patient's NK cells to eradicate minimal residual disease in cancer patients. INmune Bio’s precision medicine approach aims to treat a variety of hematologic and solid tumor malignancies, as well as chronic inflammation.