INmune Bio’s AD02 trial has bounced back from a previous US Food and Drug Administration (FDA) clinical hold, with the US biotech reporting that its primary endpoint is powering the Alzheimer’s study correctly.
The AD02 trial (NCT05318976), investigating INmune’s tumour necrosis factor (TNF) XPro, is using Early Mild Alzheimer’s Cognitive Composite (EMACC) as a primary endpoint.
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EMACC is an objective measure of cognitive function that characterises cognitive changes that occur during the early stages of the neurodegenerative disease. This is assessed by a word list learning test, category fluency test, and digit symbol coding test, amongst others.
INmune’s vice president of neuroscience CJ Barnum said the company is conducting the first trial with EMACC as a primary endpoint and that this interim analysis was critical to ensure that the EMACC is performing as “intended”.
INmune commissioned a third party to evaluate interim data of patients who completed the six-month trial. Following a blinded sample size re-estimation using the primary endpoint, the biotech concluded the trial was appropriately powered.
The FDA placed the study in a clinical hold in May 2022 due to manufacturing issues. The trial remained on hold until December 2023, when the agency also requested additional information on the long-term potency of the therapy.
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By GlobalDataThe hold was lifted in January this year, with shares in the company rising 2% at the time.
In September 2023, the company received UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval to initiate a trial with XPro in the country. Two months later, INmune Bio obtained approval to launch a Phase II clinical trial of XPro in Poland.
XPro works by reducing neuroinflammation to stop or slow the progression of cognitive and psychiatric symptoms of Alzheimer’s.
The biotech is eying an Alzheimer’s disease treatment arena that could soon see a new addition in the form of Eli Lilly’s donanemab. The drug was backed by an FDA advisory committee meeting earlier this month, drastically improving its approval chances. The space is currently dominated by Eisai and Biogen’s Leqembi (lecanemab-irmb).
