INmune Bio has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for initiating the Phase II AD02 trial of XPro (XPro1595) for the treatment of early Alzheimer’s disease (AD).

The clinical trial application (CTA) authorisation will enable the company to expand the ongoing Phase II trial in AD patients to the UK.

The CTA is part of INmune’s strategy for the international clinical development of XPro in patients with early AD.

The global, multi-centre, randomised study is also enrolling patients from Canada and Australia.

XPro met all primary and secondary endpoints in its previous open-lab Phase I study. It also showed improvements in both axonal integrity and synaptic function, as well as demonstrated significant reductions in neuroinflammation.

Using MRI imaging techniques that allow a “virtual biopsy” of the brain, patients receiving XPro treatment demonstrated improvements in the structural integrity of both grey and white matter in the brain.

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INmune Bio CEO Dr RJ Tesi said: “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 [UK] government recognises that Alzheimer’s represents not only a medical challenge but also an economic concern.

“We firmly believe that establishing clinical study sites for AD02 in the UK will accelerate patient enrolment in this vital clinical trial, offering novel treatment options to individuals grappling with this debilitating condition.”

Also known as pegipanermin, XPro is a next-generation selective inhibitor of tumour necrosis factor (TNF) that improves synaptic function and promotes remyelination.

In May this year, INmune received the US Food and Drug Administration (FDA) approval for initiating a Phase I/II clinical trial of INKmune, a natural killer cell immunotherapy, to treat metastatic castration-resistant prostate cancer.