Cognition Therapeutics (NASDAQ: CGTX) has unveiled significant findings from their Phase 2 SHINE study, demonstrating that plasma p-tau217 levels could be a crucial biomarker for identifying Alzheimer's disease patients most likely to respond to treatment with their investigational drug zervimesine (CT1812).
The groundbreaking results showed that study participants with lower baseline p-tau217 levels experienced remarkable improvements when treated with zervimesine. These patients demonstrated a 95% better performance on the ADAS-Cog 11 scale and achieved 108% higher scores on the MMSE scale compared to those receiving placebo.
Biomarker-Driven Patient Selection
Dr. Mary Hamby, Vice President of Research at Cognition Therapeutics, emphasized the dual utility of p-tau217 testing. "Beyond its diagnostic value, plasma p-tau217 assays could identify Alzheimer's patients most likely to benefit from therapies targeting beta amyloid, whether through direct immunotherapies or indirect approaches like our oligomer antagonist zervimesine," she explained.
The simplicity of measuring p-tau217 through a standard blood test makes it particularly valuable for clinical practice, offering physicians and patients an accessible tool for personalizing treatment strategies.
Advancing Precision Medicine in Neuroscience
The findings will be presented at the Hanson Wade Neuroimmunology Drug Development Summit in Boston, where Dr. Hamby will co-host a workshop focused on patient stratification for precision medicine. The session, co-led with Prothena's VP Jiri Aubrecht, will address methods for optimizing clinical trial participant selection to maximize treatment benefits.
Clinical Development Pipeline
Zervimesine's development continues through multiple clinical programs, including studies in both Alzheimer's disease and dementia with Lewy bodies (DLB). The drug's mechanism of action, targeting the sigma-2 receptor, represents a novel approach distinct from existing treatments for neurodegenerative diseases.
The ongoing START study (NCT05531656) in early Alzheimer's disease further demonstrates Cognition Therapeutics' commitment to advancing innovative treatments for neurodegenerative disorders. This strategic approach to patient selection using biomarkers could potentially accelerate the development of more effective targeted therapies for Alzheimer's disease.