Cognition Therapeutics has released data on the effect its Alzheimer’s disease drug candidate had on an exploratory endpoint in a small clinical trial, offering another look at how the molecule acts on the brain as the biotech heads toward more important readouts.
The single-center phase 2 trial randomized 16 people with mild to moderate Alzheimer’s to take CT1812, a small-molecule antagonist of the sigma-2 receptor complex, or placebo. Participants who took CT1812 in the first part of the study switched to placebo for the second part, and vice versa.
ClinicalTrials.gov lists measurement of the CT1812 plasma concentration ratio at Day 58 as the primary, and only, endpoint, although the name of the study indicates the intent to use electroencephalography (EEG) to assess the effect of the drug candidate on brain activity. Cognition focused on the quantitative EEG data in its release of the top-line data.
“Participants treated with CT1812 experienced a numerical reduction in relative theta power compared to the period when they were on placebo,” Cognition said. “While not statistically significant, these data indicate a positive impact on underlying brain function and are supported by nominally significant and directionally positive changes in AECc and alpha power.”
Cognition cited research linking increased theta power, a measure of brain waves, to the slowing of brain activity in Alzheimer’s. As such, the biotech, while acknowledging that EEG is an exploratory endpoint, framed the finding as evidence that CT1812 has positive effects on the brains of Alzheimer’s patients. AECc is a measure of connectivity, while research shows alpha power decreases with increasing impairment.
What, if anything, the brain wave results mean for the likelihood that CT1812 improves clinical outcomes is open to question. Everard Vijverberg, M.D., Ph.D., a neurologist at the Amsterdam University Medical Centers and principal investigator on the study, called the result “favorable.”
Investors' reaction seemed mixed, sending shares in Cognition—a biotech with a sub-$100 million market cap—up 9% to $2.73 in premarket trading before falling to $2.47.
The true tests of CT1812 are still to come. A 144-subject clinical trial may go some way toward answering the outstanding questions about the candidate next year if it meets its current completion deadline.