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 o ...

Core Insights - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing drugs for neurodegenerative disorders, particularly Alzheimer's disease and dementia with Lewy bodies [4] Group 1: Workshop and Presentation - Dr. Mary Hamby will co-host a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit, focusing on participant screening methods for clinical trials [1] - The workshop will include an overview of findings from Cognition's Phase 2 'SHINE' study of zervimesine (CT1812), highlighting that participants with lower p-tau217 levels showed a 95% improvement on the ADAS-Cog 11 scale and a 108% improvement on the MMSE scale compared to placebo [2][3] Group 2: Diagnostic Potential - Plasma p-tau217 assays are suggested to be valuable not only as a diagnostic tool but also for identifying Alzheimer's patients who are most likely to benefit from therapies targeting beta amyloid [3] - The measurement of plasma p-tau217 can be conducted through a simple blood test, aiding in the personalization of treatment regimens for patients [3] Group 3: Company Overview - Cognition Therapeutics is currently investigating zervimesine in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study in early Alzheimer's disease [4] - Zervimesine is believed to interact with the sigma-2 receptor, offering a distinct mechanism for treating degenerative diseases [4]

Core Insights - Cognition Therapeutics, Inc. is advancing its clinical-stage drug development focused on neurodegenerative disorders, particularly Alzheimer's disease, with a significant emphasis on precision medicine [1][4] Group 1: Clinical Developments - Dr. Mary Hamby will co-host a workshop at the Hanson Wade Neuroimmunology Drug Development Summit to discuss participant screening methods for clinical trials [1] - The Phase 2 'SHINE' study of zervimesine (CT1812) showed that participants with lower p-tau217 levels had a 95% better score on the ADAS-Cog 11 scale and 108% better on the MMSE scale compared to those on placebo [2][3] Group 2: Diagnostic Potential - Plasma p-tau217 assays can serve as a diagnostic tool to identify Alzheimer's patients who are most likely to benefit from therapies targeting beta amyloid, enhancing personalized treatment approaches [3] Group 3: Company Overview - Cognition Therapeutics is focused on developing small molecule therapeutics for age-related degenerative disorders, with zervimesine being investigated in clinical programs for dementia with Lewy bodies and Alzheimer's disease [4]

Core Insights - Cognition Therapeutics, Inc. has developed a novel chemical process for manufacturing zervimesine (CT1812), enhancing its stability at room temperature and supporting future clinical studies and potential commercial manufacturing [1][2][3] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders, particularly targeting Alzheimer's disease and dementia with Lewy bodies [4] - The company is currently investigating zervimesine (CT1812) in clinical programs, including the ongoing START study for early Alzheimer's disease [4] Product Information - Zervimesine (CT1812) is an investigational oral medication designed to treat central nervous system diseases, specifically targeting the toxic effects of amyloid beta (Aβ) and ɑ-synuclein proteins that damage neurons [3] - The new manufacturing process utilizes innovative technologies such as high throughput screening and light-induced continuous flow processing, which improves the efficiency and safety of zervimesine synthesis [2]

Core Insights - Cognition Therapeutics, Inc. has developed a novel chemical process for manufacturing zervimesine (CT1812), enhancing its stability at room temperature and supporting future clinical studies and potential commercial manufacturing [1][2]. Group 1: Chemical Process and Patent Applications - The new manufacturing process utilizes innovative technologies such as high throughput screening and light-induced, continuous flow processing, which improves the efficiency and safety of zervimesine synthesis [2]. - Provisional patent applications have been filed for the new chemical process and a preferred polymorphic form of zervimesine [1]. Group 2: Zervimesine (CT1812) Overview - Zervimesine (CT1812) is an investigational oral medication aimed at treating central nervous system diseases, including Alzheimer's disease and dementia with Lewy bodies (DLB) [3]. - The drug targets the toxic effects of amyloid beta (Aβ) and ɑ-synuclein proteins, which are associated with neuron damage and cognitive decline in these diseases [3]. Group 3: Company Background - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [4]. - The company is currently investigating zervimesine in clinical programs for DLB and Alzheimer's disease, including the ongoing START study [4].

Core Insights - Cognition Therapeutics, Inc. announced topline results from the SHIMMER study of zervimesine (CT1812) in dementia with Lewy bodies, which will be presented at the International Lewy Body Dementia Conference [1][2] - The study demonstrated significant efficacy signals, with zervimesine-treated participants showing improvements across various symptoms compared to placebo [2][5] Study Overview - The SHIMMER study was a Phase 2 clinical trial involving 130 adults with mild-to-moderate dementia with Lewy bodies, randomized to receive either zervimesine or placebo for six months [8][9] - The study met its primary endpoint of safety and tolerability, with most treatment-related adverse events being mild or moderate [4][5] Efficacy Results - Zervimesine-treated participants scored an average of 86% better on the neuropsychiatric inventory (NPI) A-L compared to placebo [2][5] - Participants on zervimesine preserved 52% more ability in activities of daily living (ADCS-ADL) and showed a 91% reduction in cognitive fluctuations [3][5] - Improvements in motor function were also noted, with zervimesine-treated patients maintaining 62% better motor function than those on placebo [3][5] Implications for Patients - The positive outcomes suggest that zervimesine may allow patients with dementia with Lewy bodies to live at home longer with the support of caregivers, reducing the need for care facility placement [4][5] - The study highlights the potential for zervimesine to alleviate debilitating neuropsychiatric and motor symptoms associated with the disease [2][4] Company Background - Cognition Therapeutics is focused on developing innovative therapeutics for age-related degenerative disorders, with zervimesine being a lead candidate currently investigated in clinical programs for dementia with Lewy bodies and Alzheimer's disease [11]

Core Insights - Cognition Therapeutics, Inc. announced strong therapeutic responses for zervimesine (CT1812) in patients with mild-to-moderate dementia with Lewy bodies (DLB), showing significant improvements across various measures compared to placebo [1][2][3] Study Results - The Phase 2 SHIMMER study involved 130 adults with mild-to-moderate DLB, demonstrating that zervimesine-treated participants scored 86% better on behavioral outcomes, 52% better on activities of daily living, 91% better on cognitive fluctuations, and 62% better on motor symptoms compared to placebo [2][3][6] - Zervimesine treatment resulted in fewer hallucinations, delusions, anxiety, and agitation in patients, which are common debilitating symptoms of DLB [2][4] - The study met its primary endpoint of safety and tolerability, with most treatment-related adverse events being mild or moderate [4][6] Mechanism of Action - Zervimesine is designed to penetrate the blood-brain barrier and selectively bind to the sigma-2 receptor complex, which is involved in regulating cellular processes disrupted by neurodegenerative disease drivers [8] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina, with zervimesine as its lead candidate [9]

Core Viewpoint - Cognition Therapeutics, Inc. is making significant progress in its clinical programs for neurodegenerative disorders, particularly Alzheimer's disease and dementia with Lewy bodies, and is preparing for key presentations and regulatory meetings in early 2025 [2][3]. Company Developments - CEO Lisa Ricciardi will participate in conferences during the JP Morgan Healthcare Conference week to discuss advancements made in 2024 [1][2]. - The company achieved positive topline results from its Phase 2 SHIMMER study in patients with dementia with Lewy bodies, with findings to be presented at the International Lewy Body Dementia Conference in January 2025 [2]. - Cognition Therapeutics is preparing for an end-of-Phase 2 meeting with the FDA to review results from its SHINE study in mild-to-moderate Alzheimer's disease, marking an important regulatory milestone [2]. - The company received clearance for the generic name of its candidate, CT1812, which will be known as zervimesine [2]. Upcoming Events - Cognition Therapeutics will present at the Longwood Healthcare Leaders Stanford Summit on January 11, 2025, and at the Sachs 8th Annual Neuroscience Innovation Forum on January 12, 2025 [3]. - The panel discussions will focus on accelerating drug development and innovations in Alzheimer's disease and other cognitive disorders [3]. Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina [3]. - The lead candidate, zervimesine, is being investigated in clinical programs for Alzheimer's disease, dementia with Lewy bodies, and dry age-related macular degeneration [3]. - The company believes that zervimesine and its pipeline of Ï-2 receptor modulators can effectively regulate impaired pathways in these diseases, offering a distinct approach compared to other treatments [3].

Core Insights - Cognition Therapeutics, Inc. reported positive results from the exploratory Phase 2 SHIMMER study, indicating that CT1812 showed strong therapeutic responses in patients with dementia with Lewy bodies (DLB) across various measures [1][2] Study Results - The SHIMMER Phase 2 study involved 130 patients with mild-to-moderate DLB, who were randomized to receive either CT1812 or placebo for six months [1] - The study met its primary endpoint of safety and tolerability, with DLB patients treated with CT1812 showing significant improvements in behavioral, functional, cognitive, and movement measures compared to placebo [2] - There was an 82% slowing in the total neuropsychiatric inventory (NPI), with notable reductions in anxiety, hallucinations, and delusions among CT1812 treated patients [2] - Caregiver distress also saw a marked reduction, indicating a positive impact on the daily lives of patients receiving the drug [3] - Participants treated with CT1812 experienced a 91% decline in fluctuations in attention, demonstrating a slowing decline across all three cognitive measures compared to placebo [3] Financial Position - As of September 30, 2024, Cognition Therapeutics reported cash and cash equivalents of approximately $22.0 million, with total grant funds remaining from the NIA at $53.6 million [5] - The company estimates it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025 [5] Stock Performance - Following the positive study results, CGTX stock increased by 93.45%, reaching $0.88 [6]

Clinical Trial Results - CT1812 demonstrated strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB) in the exploratory Phase 2 SHIMMER study [1] - The study met its primary endpoint of safety and tolerability, with CT1812-treated patients showing improvement in behavioral, functional, cognitive, and movement measures compared to placebo [2] - There was an 82% slowing in the total neuropsychiatric inventory (NPI), with significant reductions in anxiety, hallucinations, and delusions in the CT1812-treated arms [2] - Participants treated with CT1812 experienced a 91% slowing in the decline of attention fluctuations compared to placebo [2] Study Design and Details - The SHIMMER Phase 2 study enrolled 130 patients with mild-to-moderate DLB, randomized to receive one of two oral doses of CT1812 or placebo daily for six months [2] - The study is supported by a $30 million grant from the National Institute on Aging of the National Institutes of Health (NIH) [8] - The study is being conducted at over 30 sites in the United States, many of which are Lewy Body Dementia Association (LBDA) centers of excellence [8] Future Plans and Expectations - Cognition Therapeutics plans to advance CT1812 into late-stage trials based on the positive results from the SHIMMER study [1] - The company will present detailed data at the International Lewy Body Dementia Conference (ILBDC) in January 2025 [2] - Cognition Therapeutics will review the topline efficacy and safety findings with the FDA in an end-of-Phase 2 meeting [3] About CT1812 - CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex [10] - CT1812 is currently being investigated in clinical programs for Alzheimer’s disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD) [12] About Dementia with Lewy Bodies (DLB) - DLB is the second most common cause of dementia, affecting an estimated 1.4 million Americans [6] - The disease is caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies within brain neurons [6] - DLB disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems, leading to symptoms such as hallucinations, delusions, and movement disorders [6]