Inmune Bio Inc. Receives Approval From the U.K. Medicines and Healthcare Products Regulatory Agency for Phase 2 Clinical Trial in Alzheimer's Disease
Wednesday, September 06, 2023
INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company dedicated to developing treatments that harness the innate immune system to combat diseases, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2 trial for Early Alzheimer's disease (AD) with its drug XPro™. This authorization for clinical trials in the United Kingdom is part of INmune Bio's global clinical development strategy for XPro™, which also includes patient enrollment in Australia and Canada.
The Phase 2 clinical trial, named AD02, is a worldwide, multi-center, randomized study involving patients diagnosed with early-stage Alzheimer's disease. INmune Bio successfully met all primary and secondary endpoints in a prior Phase I open-label trial. Patients with AD who received XPro™ treatment experienced significant reductions in neuroinflammation, improved axonal integrity, and enhanced synaptic function. Advanced MRI imaging techniques, capable of performing a "virtual biopsy" of the brain, demonstrated improvements in both gray and white matter structural integrity following XPro™ treatment.
Dr. RJ Tesi, CEO of INmune Bio, expressed confidence in the UK as an ideal location for Alzheimer's disease clinical studies. He noted the region's highly advanced medical community and the strong motivation of patients and caregivers to participate in Alzheimer's trials. Additionally, the government's recognition of Alzheimer's as a significant medical and economic challenge further supports their clinical research endeavors.
The United Kingdom faces a significant Alzheimer's disease burden, with one of the highest rates in the western world, totaling 47 cases per 100,000 patients, and nearly one million individuals diagnosed with dementia. In 2021, the cost of dementia care in the UK reached £25 billion, making dementia the projected costliest health condition by 2030. This situation is not unique to the UK, as the global dementia population is expected to triple by 2050. The UK's commitment to medical research and the presence of the National Health Service (NHS) position it as a pivotal player in advancing therapies for Alzheimer's disease.
XPro™ (XPro1595, pegipanermin) represents a next-generation selective inhibitor of tumor necrosis factor (TNF) currently undergoing clinical trials. It differentiates itself from existing TNF inhibitors by specifically neutralizing soluble TNF (sTNF) while sparing trans-membrane TNF (tmTNF) and TNF receptors. XPro™ holds significant promise for patients with neurologic diseases by reducing neuroinflammation, mitigating neurodegeneration, enhancing synaptic function, and promoting remyelination. For further insights into the importance of targeting neuroinflammation in the brain to enhance cognitive function and restore neuronal communication, please visit the relevant section on INmune Bio's website.
