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INmune Bio Announces First Patient Dosed in Phase 2 XPro1595 Trial for Treatment of Neuroinflammation as a Cause of Alzheimer’s disease
INmune Bio Plans to Enroll 201 Patients in a 6-Month Study to Evaluate Cognitive Function in Patients with Mild Alzheimer’s Disease Boca Raton, Florida, April
About this update from Inmune Bio Inc.
[{"type":"text","content":"INmune Bio Plans to Enroll 201 Patients in a 6-Month Study to Evaluate Cognitive Function in Patients with Mild Alzheimer’s Disease\nBoca Raton, Florida, April 13, 2022 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INMB” or “the Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces dosing of the first patient enrolled in its Phase 2 trial using XPro1595 (XPro™) to treat neuroinflammation as a cause of Alzheimer’s disease (AD). The Phase 2 multicenter, international trial is a blinded, randomized, placebo-controlled six-month Phase 2 trial designed to evaluate XPro™ to treat cognition and function in patients with mild AD and biomarkers of inflammation. The company plans to enroll patients at sites located near major metropolitan areas in Australia, in Canada and in the United States. “The Phase 1 study data clearly showed an improvement in multiple biomarkers related to AD pathology, including a reduction in neuroinflammation and neurodegeneration, and an improvement in biomarkers of neurorepair and neuron communication,” said Dr. C.J. Barnum, INmune Bio’s Vice President of CNS Development. “This Phase 2 study will determine whether improvement in these biomarkers translates into a clinical benefit of improved cognition and function in patients with mild AD and biomarkers of inflammation.” About the Phase 2 XPro1595 / XPro™ Study: Based on data from the Phase 1 trial, the Company expects half of the patients screened for participation in the Phase 2 trial with mild AD will have elevated biomarkers of inflammation and be eligible to enroll. Patients will be assigned in a randomized manner in a 2:1 (XPro™ vs placebo) ratio between the two arms of study. All patients will be offered the opportunity to participate in an extension trial after participation in the 6-month Phase 2 trial. In the extension trial, all patients will receive XPro™ and have continued monitoring of biomarkers of inflammation and cognition up to an additional 12 months. Inflammation is increasingly recognized as a cause of AD, and XPro™ addresses the inflammatory factor that sits at the apex of inflammation, soluble Tumor Necrosis Factor (sTNF). “As recently as two weeks ago, a well-respected peer reviewed journal (Nature Genetics) highlighted th...