Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies and Alzheimer's Disease

- Zervimesine's impact on debilitating DLB behavioral symptoms highlighted in podium presentation -

- Plasma p-tau217 levels can identify Alzheimer's patients most likely to benefit from zervimesine treatment -

- Plasma and CSF biomarkers support zervimesine's impact on Alzheimer's disease biology -

PURCHASE, N.Y., July 29, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ:CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, presented results from the Phase 2 COG1201 SHIMMER study (NCT05225415) of zervimesine (CT1812) in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference (AAIC 2025).

As previously reported, the SHIMMER study met its primary endpoint of safety and tolerability. Results showed that zervimesine treatment had a positive impact across neuropsychiatric, cognitive, motor, and functional scales. After six months of treatment, DLB patients treated with zervimesine scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI-12). This tool measures 12 separate behavioral symptoms, including hallucinations, delusions, and anxiety, which are hallmarks of DLB. The findings were presented by James E. Galvin, MD, MPH during a Featured Research Session on July 29, 2025.

"Among the NPI-12 components, hallucinations, delusions, and anxiety are often considered most troubling to patients and their care partners," stated Dr. Galvin, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the SHIMMER study director. "These behavioral symptoms are also some of the most challenging to treat, since DLB patients have severe and sometimes dangerous reactions to many commonly used neuropsychiatric drugs. This made zervimesine's impact even more notable."

Results from the Phase 2 COG0201 ‘SHINE' study (NCT03507790) of zervimesine in Alzheimer's disease were also presented at AAIC. The SHINE study met its primary endpoint of safety and tolerability. An analysis was conducted on a subgroup of participants whose Alzheimer's disease brain pathology was less pronounced, as determined by lower levels of a protein called p-tau217 in their blood. Approximately half of this subgroup was identified as having mild Alzheimer's disease and half with moderate Alzheimer's disease by the mini mental state exam (MMSE). The MMSE is a standard test that measures memory, attention, language and other functions to evaluate the degree of a person's cognitive impairment.

SHINE participants with lower p-tau217 had a more robust response to zervimesine compared to those with higher p-tau217 levels regardless of their MMSE scores. Zervimesine was shown to arrest further cognitive deterioration in people with mild or moderate Alzheimer's disease by 129% and 91%, respectively. Anthony Caggiano, MD, PhD, Cognition's CMO and head of R&D, explained, "This was an important finding as we now know we can identify patients who are more likely to benefit from zervimesine treatment through a simple blood test for p-tau217."

Additionally, two research posters delve into the mechanism that underlies the impact of zervimesine in Alzheimer's disease. These posters summarize analyses of the cerebrospinal fluid (CSF) and plasma biomarkers from SHINE participants with lower levels of p-tau217. In these individuals, significant reductions were observed in the level of plasma glial fibrillary acidic protein (GFAP), a protein associated with neuroinflammation. In addition, there were trends towards the normalization of neurofilament light (NfL), a protein associated with neurodegeneration, and amyloid beta species (Aβ40 and 42).

"The biomarker evidence we're presenting at AAIC shows that zervimesine treatment had an effect on proteins involved in neuroinflammation, synapse health and neurodegeneration," added Mary Hamby, PhD, VP of research. "This is consistent with previously reported results showing significant decreases in NfL and normalizing trends in amyloid beta species in the CSF of people treated with zervimesine. This is encouraging evidence that zervimesine is impacting the underlying Alzheimer's disease biology."

Dr. Galvin's slide presentation and Cognition's three posters will be available on the Cognition Therapeutics website in accordance with the conference's embargo policy.

About the SHIMMER Study in Dementia with Lewy Bodies

The SHIMMER study (COG1201; NCT05225415) is an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. A total of 88 participants were randomized to the two treatment arms and 42 to the placebo arm. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.

The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA).

About the SHINE Study in Mild-to-Moderate Alzheimer's Disease

The SHINE study (NCT03507790) is a double-blind, placebo-controlled Phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease who were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months. The primary endpoint was safety and tolerability. The key secondary endpoint of cognition was ADAS-Cog 11. Exploratory endpoints included change in MMSE, ADAS-Cog 13, ADCS-ADL and -CGIC as well as pre-specified subgroup analyses included a comparison of cognitive and functional changes in participants with plasma p-tau217 levels above and below the median.

The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million.

About Zervimesine (CT1812)

Zervimesine (CT1812) is an investigational, oral, once-daily pill in development 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 – Aβ and ɑ-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. Zervimesine has been generally well tolerated in clinical studies to date. Zervimesine has been granted FDA Fast Track designation in Alzheimer's disease.

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 and retina. We currently are 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 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases that are 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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