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INmune Bio's Alzheimer's drug misses mid-stage goal, shares sink to record low
- 6/30/2025
(Reuters) -INmune Bio said on Monday its experimental Alzheimer's drug failed to improve cognitive functions in patients with early stages of the mind-robbing disease in a mid-stage study, sending its shares plunging about 60% to a record low.
The treatment, XPro, is designed to target and inhibit inflammatory signals associated with a type of protein called tumor necrosis factor without suppressing the immune system.
The study enrolled 208 patients with mild Alzheimer's, or mild cognitive impairment, an early sign of the disease, who were randomly chosen to receive a weekly subcutaneous injection of XPro or a placebo for 24 weeks.
The main goal was the change in the EMACC, or Early Mild Alzheimer's Cognitive Composite. EMACC was developed to provide an accurate measure of cognitive change in early stage patients using a collection of familiar, widely used and validated neuropsychological tests.
Despite no significant effects in the overall intent-to-treat trial group, XPro showed cognitive, behavioral, and biological benefits in a specific subgroup of 100 early Alzheimer's patients with inflammation markers, the company said.
The drug was safe and well-tolerated with injection site reaction the most common adverse event.
"We recognize there is work to be done, and that work will require financial resources, we plan to explore partnering opportunities (to advance the treatment)," CFO David Moss said on a call with analysts.
INmune Bio plans to discuss the trial goals as well as the path for a pivotal trial for the treatment with the U.S. Food and Drug Administration in the fourth quarter.
Treatments for Alzheimer's approved so far, including Eisai and Biogen's Leqembi, and Eli Lilly's Kisunla, are designed to clear sticky clumps of a protein called amyloid beta in the brain, believed to be a hallmark of the disease. These drugs, however, carry hefty price tags and come with the risk of serious brain swelling and bleeding.
INmune Bio's shares were down 60.41% at $2.11 in late morning trading. The stock had gained 14% this year to Friday's close.
(Reporting by Mariam Sunny and Siddhi Mahatole in Bengaluru; Editing by Alan Barona and Sriraj Kalluvila)