INmune Bio has obtained approval for a clinical trial application (CTA) to launch a Phase II clinical trial of XPro for early Alzheimer’s disease (AD) in Poland. 

The approval has been granted under the EU Clinical Trials Regulation.

The multicentre, international, randomised trial will enrol early AD patients with higher inflammation biomarkers. 

It is currently underway enrolling participants in the UK, Canada and Australia.

In September this year, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted approval for the company to commence the trial of XPro.

INmune Bio anticipates receiving further regulatory approvals for the Phase II AD trial in two to six more countries in the EU soon. 

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A Phase I open-label trial of XPro met all primary and secondary endpoints. 

Furthermore, AD patients in the XPro arm showed a decline in neuroinflammation, improved axonal integrity and enhanced synaptic function. 

A selective tumour necrosis factor (TNF) inhibitor, XPro could lower neuroinflammation and neurodegeneration while boosting remyelination and synaptic function.

INmune Bio CEO RJ Tesi said: “Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment in the Phase II trial. 

“Additionally, the initiation of sites in the EU establishes the groundwork for realising our long-term goal of conducting a global Phase III trial.”

The company also obtained nearly $2.8m in a cash refund from Australia as a result of a tax rebate for research and development activities. 

INmune Bio plans to utilise the amount to reinvest in the clinical programmes of the company.