INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in Europe
The Company received regulatory approval to extend its Phase II trial of XPro™ in individuals with early Alzheimer’s disease in Poland, with additional European Union (EU) countries expected to open soon.
The Company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive.
Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) — INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient’s innate immune system to combat disease, has received acceptance of a Clinical Trial Application (CTA) under EU Clinical Trials Regulation to initiate a Phase II trial in Early Alzheimer’s Disease (AD) with XPro™ in Poland. Additional regulatory approval for the Phase II AD clinical trial is expected from at least two to potentially six more EU countries in the upcoming months. The EU approval is part of the Company’s international clinical development strategy for XPro™ in patients with early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom.
The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer’s disease who have biomarkers of elevated inflammation. In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro™ demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a “virtual biopsy” of the brain, treatment with XPro™ demonstrated improvements in the structural integrity of both gray and white matter in the brain.
“We are delighted with the addition of clinical sites in the EU. Countries were selected based on their previous experience in Alzheimer’s disease research and their interest in novel therapies,” said RJ Tesi M.D., CEO of INmune Bio. “Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial.”
The Company also recently received a cash refund of approximately $2.8 million pursuant to a research and development tax incentive from Australia. The Company will use the rebate to reinvest in its clinical programs.
“We are delighted with the ongoing receipt of R&D rebates from research-friendly jurisdictions like Australia. These funds provide a non-dilutive funding source, allowing INmune to reinvest in expanding recruitment and enrollment not only in Australia and Canada but also in our newer locations in the U.K. and the EU,” remarked David Moss, Chief Financial Officer.
My take: Adding more jurisdictions approving the AD trial not only bodes well for enrollment but sets the company up for a well received phase 3.
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