INmune Bio’s Phase 2 MINDFuL Trial Given Green Light to Start in Canada

XPro1595 to be tested in 201 people with mild Alzheimer's in 3 countries

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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INmune Bio received the green light for MINDFul, its Phase 2 trial of XPro1595 — an experimental treatment for Alzheimer’s disease — to begin in Canada.

Health Canada, Canada’s regulatory health authority, issued a “no objection letter” where it gives the company official permission to test XPro1595 in people with mild Alzheimer’s in the country.

MINDFuL (NCT05318976) is ongoing in Australia, where the first patient recently completed dosing and enrolled in an open-label extension study.

“Enrolling patients in both Canada and Australia gives us access to a larger patient population that should help increase the pace of enrollment,” R.J. Tesi, MD, INmune Bio’s CEO , said in a press release.

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Study seeks 201 patients, ages 60 to 85, in the U.S., Australia, and Canada

The aim is to recruit up to 201 people, ages 60–85, with mild Alzheimer’s and biomarkers of brain inflammation across multiple sites in the U.S., Australia, and Canada.

While the company continues to collaborate with the U.S. Food and Drug Administration, which placed the trial on clinical hold until additional manufacturing information is provided, it is now working to set up sites and begin enrolling patients in Canada.

“We hope to further expand the geographical footprint of the trial soon,” Tesi said.

The trial remains open in Australia and continues to enroll patients. Those interested in enrolling may contact the company at (858) 964-3720 or via email at [email protected].

XPro1595 is a human-made protein designed to bind to and block a soluble form of tumor necrosis factor (TNF), a molecule that triggers inflammation and is present in high amounts in the brain of people with Alzheimer’s.

It also is designed to be able to cross the blood brain barrier, a layer made up of closely spaced cells that helps bar harmful substances circulating in the bloodstream from reaching the brain and spinal cord. If XPro1595 could lower inflammation in the brain by blocking TNF, then it would be expected to slow or stop the progression of Alzheimer’s symptoms.

Enrolling patients in both Canada and Australia gives us access to a larger patient population that should help increase the pace of enrollment

MINDFuL will evaluate how safe and well-tolerated XPro1595 is in people with mild Alzheimer’s, and also how well it may lessen inflammation in the brain and thereby improve cognition and function.

Those who enter the trial will be randomly assigned to receive either 1 mg/kg of XPro1595 or a placebo, once-a-week, via subcutaneous (under-the-skin) injection, for 23 weeks (nearly six months).

All of those who complete the trial will have the option to participate in an open-label extension study (NCT05522387) in which all will be treated with XPro1595 for up to an additional year. They will be monitored for any side effects, inflammation biomarkers, and changes in cognition over the duration of the study.