Cognition Therapeutics Successfully Passes Pre-defined Futility Analysis of Phase 2 Study of Oral Zervimesine (CT1812) in Geographic Atrophy

Globe Newswire 26-Feb-2025 7:00 AM

Masked Analysis Shows Participants Receiving Oral Zervimesine for at Least 6 Months Experienced Slower Lesion Growth than Participants Receiving Placebo

Following the Futility Analysis, Management Concluded the Phase 2 Study, Preserving Capital

Full Analysis will be Provided in the Second Quarter of 2025

PURCHASE, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported a positive outcome of an analysis of masked data from the ongoing ‘MAGNIFY' Phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The purpose of this type of analysis, known as a "futility analysis" is to determine if a drug candidate is showing signals of efficacy. Cognition's contract research organization conducted the analysis to protect the integrity of the clinical trial.

Results of the futility analysis from the first 57 participants who completed at least 6 months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo.

To date, the MAGNIFY study (NCT05893537) has enrolled 100 participants. All participants are completing a final clinic visit in February 2025. Cognition intends to unblind the study at the end of February and provide a complete analysis of the study, including 12 months of dosing, in the second quarter of 2025.

The Company continues to believe that zervimesine has the potential to alter the biological processes that contribute to dry AMD. Cognition and collaborators have generated compelling preclinical evidence to support this. As previously reported, concluding the MAGNIFY study early enabled the Company to preserve financial resources, which will be redeployed to other indications.

In December 2024, Cognition reported that the Phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies (DLB) met its primary endpoint of safety and tolerability. In the DLB study, zervimesine-treated participants performed an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI); 52% better on the ADCS-ADL; 91% better on the clinician's assessment of fluctuations (CAF); and 62% better on the UPDRS Part III, a measure of motor function such as gait, balance, and tremor. Cognition's Phase 2 SHINE study of zervimesine in mild-to-moderate Alzheimer's disease also met its primary endpoint of safety and tolerability. In a biomarker-defined subgroup of the SHINE study, zervimesine-treated participants experienced a 95% reduction of cognitive decline as measured by ADAS-Cog 11 relative to placebo. We plan to schedule end-of-Phase 2 meetings with the U.S. Food and Drug Administration to review these results and discuss the design of registrational studies in Alzheimer's disease and DLB.

About Zervimesine (CT1812) 
Zervimesine (CT1812) is an investigational oral, once-daily pill being developed for the treatment of CNS diseases such as Alzheimer's disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain - Aß and ?-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person's ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer's and DLB. 

The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.

About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. 

Forward-Looking Statements 
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