CT-1812

- Zervimesine-treated participants tested 86% better on behavioral outcomes (NPI 12), 52% on activities of daily living, 91% on cognitive fluctuations, and 62% on motor symptoms as compared to placebo - - Additional presentations highlight positive clinical and biomarker effects of zervimesine in the low p-tau217 population in Phase 2 Alzheimer’s disease study - July 16, 2025 -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that James E. Galvin, MD, MPH will present results from the Phase 2 ‘SHIMMER’ study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer’s Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025 in the 8:00 a.m. ET Featured Research Session. “The results of the Phase 2 SHIMMER study give hope to the millions of people living with DLB and their healthcare teams, who struggle to treat this complex disease,” stated Dr. Galvin. “My colleagues and I believe that there is great potential in a once-daily oral medication that slows disease progress while simultaneously reducing the severity and frequency of some of the most troublesome symptoms of DLB.” DLB is the second most common cause of dementia, affecting approximately 1.4 million Americans. People living with DLB experience a variety of symptoms, which typically include neuropsychiatric features such as hallucinations, delusions and agitation; cognitive impairment; Parkinsonian movement disorders; REM sleep behavior disorder; and fluctuations in attention and awareness. Currently no disease-modifying therapeutics are approved for DLB. Anthony Caggiano, MD, PhD, Cognition’s CMO and head of R&D added, “Zervimesine’s broad neuroprotective mechanism is illustrated by the favorable results observed in the Phase 2 SHIMMER study in DLB. In the SHIMMER study, zervimesine treatment slowed the progression of DLB’s diverse symptomology, with a meaningful impact on neuropsychiatric, motor, functional, and cognitive measures. Results from the Phase 2 ‘SHINE’ study in people with Alzheimer’s disease add further evidence to zervimesine’s neuroprotective properties. We look forward to presenting results from both studies at AAIC.” The SHINE study was a signal-finding trial that showed zervimesine treatment preserved cognitive and functional abilities better than placebo in people with mild-to-moderate Alzheimer’s disease. This impact was more robust in participants with lower levels of p-Tau217, who experienced a 95% slowing of cognitive decline at six months as measured by ADAS-Cog 11 compared to placebo. Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer’s study at AAIC. Dr. Galvin’s slide presentation as well as Cognition’s three posters will be available on the Cognition Therapeutics website in accordance with the conference’s embargo policy. Featured Research Session: •Baseline Characteristics and Results of the Phase 2 COG1201 SHIMMER Study of Zervimesine (CT1812): 8:00-8:45 a.m. on July 29 Posters: •Zervimesine (CT1812) Treatment Benefits Patients with Lower Baseline Plasma p-tau217 Across the Mild-to-Moderate AD Spectrum: (#106858) July 27 •Exploratory CSF proteomic analysis of a pre-specified pTau217 subgroup from the SHINE clinical trial identifies biomarkers correlated with cognitive improvement in Alzheimer’s disease patients treated with zervimesine: (#102120) July 27 •An exploratory proteomics plasma biomarker analysis of the SHIMMER Phase 2 clinical trial to assess the pharmacodynamic effect of the sigma-2 receptor modulator zervimesine in dementia with Lewy bodies patients: (#106855) July 27 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). 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. 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. 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. 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