INmune Bio has commenced the dosing of patients in a Phase Ib clinical trial of XPro1595 being conducted to help treat Alzheimer’s disease.
XPro1595 is an anti-inflammatory drug intended to specifically neutralise the soluble tumour necrosis factor (sTNF) with no effect on trans-membrane TNF (tmTNF) and TNF receptors.
The drug is expected to work by reducing neuroinflammation in Alzheimer’s patients.
INmune Bio Neuroscience director CJ Barnum said: “This is a significant milestone for INmune Bio and for a field desperate for novel approaches to treat approximately 50 million people suffering from Alzheimer’s worldwide.
“XPro1595 targets the dysfunctional immune system that gives rise to chronic neuroinflammation in Alzheimer’s patients. The goal of this Phase Ib study is to demonstrate that XPro1595 is safe and can reduce neuroinflammation.”
The open-label, multi-centre Phase Ib trial will assess the safety, tolerability and efficacy of XPro1595 in people suffering from mild to moderate Alzheimer’s.
In Australia, the study is enrolling patients with increased levels of high sensitivity c-reactive protein (hs-CRP), an inflammatory biomarker in the blood.
The trial will primarily investigate the ability of the drug to decrease neuroinflammation, established using invasive and non-invasive inflammation biomarkers.
The company also aims to determine the dose for a larger Phase II disease modification trial.
Primary outcomes of the study are the number and percentage of participants with a treatment-emergent adverse event over 12 weeks of therapy period.
INmune Bio CEO RJ Tesi said: “This approach to fighting one of the most devastating diseases of our time, which differs from current therapies targeting amyloid plaques, could be a key to cracking the code of Alzheimer’s disease.
“Although the first study is designed to demonstrate safety, we are collecting data that will inform on the potential for XPro1595 as an effective therapy for Alzheimer’s patients.”