INmune Bio Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Phase 2 Clinical Trial in Alzheimer’s Disease

2023-09-08

临床2期临床结果临床申请

The authorization provides approval for the Company to expand the ongoing Phase 2 trial of XPro™ in patients with early Alzheimer’s disease to the U.K.

INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today received authorization of its Clinical Trial Application (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2 trial in Early Alzheimer’s disease (AD) with XPro™. The U.K. CTA is part of the Company’s international clinical development strategy for XPro™ in patients with early AD. The trial is also enrolling patients in Australia and Canada.

The AD02 Phase 2 clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease. In a prior Phase I open-lab trial, INmune Bio met all primary and secondary endpoints. AD patients treated with XPro™ exhibited significant reductions in neuroinflammation, improved axonal integrity, and improved synaptic function. Using sophisticated MRI imaging techniques that allow a “virtual biopsy” of the brain, treatment of XPro™ demonstrated improvements in the structural integrity of both gray and white matter in the brain.

"We believe that the United Kingdom serves as an optimal setting for conducting clinical studies on Alzheimer's disease. The medical community in the region is highly sophisticated, and patients, along with their dedicated caregivers, exhibit strong motivation to Alzheimer’s trials. Moreover, the government recognizes that Alzheimer’s represents not only a medical challenge but also an economic concern," remarked Dr. RJ Tesi, CEO of INmune Bio. "We firmly believe that establishing clinical study sites for AD02 in the UK will accelerate patient enrollment in this vital clinical trial, offering novel treatment options to individuals grappling with this debilitating condition."

The UK has one of the highest rates of AD in the western world (47 cases per 100,000 patients) with almost one million patients diagnosed with dementia. In 2021, the estimated cost of dementia care in the UK was £25 billion. Dementia is expected to be the costliest health condition by 2030 and the UK is not in a unique situation. Globally, the number of people living with dementia is projected to triple by 2050. As a result of the quality of its medical research and the presence of the National Health Service, the UK plays an important role in advancing therapies for AD.

About XPro

XPro™ (XPro1595, pegipanermin) is a next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing neurodegeneration while improving synaptic function and promoting remyelination. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INmune Bio, Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease, and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

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