Full Press Release Details
Cognition Therapeutics' Successfully Passes
Pre-defined Futility Analysis of Phase 2 Study of Oral Zervimesine (CT1812) in Geographic Atrophy
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
PURCHASE, NY - February 26, 2025 -- 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
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
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 - A 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
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statements regarding our expected runway, product candidates, including zervimesine (CT1812), and any expected or implied benefits
or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our
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