INmune Bio's Alzheimer's drug misses mid-stage goal, shares sink to record low

INmune Bio INMB 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, a widely used tool to measure a cognitive decline.

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.

CEO Raymond Tesi told Reuters that the drug stabilized cognition in patients, and "they will continue to remain stable, and the placebo group will continue to fall away ... get worse."

The drug was safe and well-tolerated with injection site reaction the most common adverse event.

"We recognize there is work to be done ... we plan to explore partnering opportunities (to advance the treatment)," CFO David Moss said on a conference call.

"If Wall Street was a little more forgiving, we would be able to raise money to develop the drug our own," Tesi said.

INmune 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 4523 and Biogen's BIIB Leqembi, and Eli Lilly's LLY Kisunla, are designed to clear sticky clumps of a protein called amyloid beta in the brain. They also carry hefty price tags and the risk of serious brain swelling and bleeding.