Alzheimer’s disease was first described over 100 years ago. Today, we recognize that it is a complicated disease that may have more than one cause. Given the heterogeneity of Alzheimer’s disease, a single therapy is unlikely to be effective for all patients. Ideally, biomarkers will help clinicians determine the cause of dementia in a given patient. INmune Bio is focused on neuroinflammation as a cause of Alzheimer’s disease. Inflammatory biomarkers help us align our treatment with the patients’ pathophysiology (inflammation) allowing clinical teams to identify patients most likely to respond to a treatment. A biomarker directed treatment approach in dementia is rare. We believe Alzheimer’s disease as an immunological disease with neurologic symptoms of dementia. Approaching Alzheimer’s disease as an immunologic disease changes trial design because there are many immunologic biomarkers available. This allows us to do shorter trials in a small number of carefully selected patients who are intensively studied. This approach provides the insight needed to determine if the drug is providing benefit to patients and help us decide if a larger study is warranted. In the current study, inflammatory biomarkers will be used to:
- Identify Alzheimer’s disease patients mostly likely to respond to XPro1595 (patients with increased neuroinflammation)
- Demonstrate that XPro1595 reduces neuroinflammation
- Determine if decreasing neuroinflammation improves symptoms of Alzheimer’s disease
Phase Ib clinical trial in patients with mild to moderate Alzheimer’s Disease and elevated levels of inflammation in their blood
The trial will enroll patients with mild to moderate Alzheimer’s disease and biomarkers of inflammation in their blood. The trial will treat patients for twelve weeks to demonstrate safety and proof of biology (reduction in inflammation). Patients will have 5 groups of inflammatory biomarkers studied before treatment, at the half way point, and at the end of the study. Cognitive and psychiatric symptoms will be also be measured.