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About Cognition Therapeutics Inc.
Cognition Therapeutics Inc. (NASDAQ: CGTX) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative small-molecule therapeutics targeting age-related degenerative disorders of the central nervous system (CNS) and retina. Founded in 2007 and headquartered in Pittsburgh, Pennsylvania, the company leverages proprietary biology and chemistry platforms to address unmet medical needs in neurodegenerative diseases.
Core Focus and Pipeline
The company’s lead candidate, zervimesine (formerly CT1812), is an orally administered small molecule designed to penetrate the blood-brain barrier and selectively bind to the sigma-2 (σ-2) receptor complex. This novel mechanism aims to displace toxic oligomers of amyloid beta (Aβ) and α-synuclein, which are implicated in the progression of Alzheimer’s disease (AD) and dementia with Lewy bodies (DLB). By protecting synapses and restoring cellular function, zervimesine offers a potentially disease-modifying approach distinct from symptomatic treatments.
Cognition Therapeutics is advancing zervimesine through multiple clinical programs:
- Alzheimer’s Disease: The Phase 2 SHINE study demonstrated a 95% reduction in cognitive decline in a biomarker-defined subgroup.
- Dementia with Lewy Bodies (DLB): The SHIMMER Phase 2 trial showed significant improvements across behavioral, cognitive, and motor symptoms, with a favorable safety profile.
- Dry Age-Related Macular Degeneration (dry AMD): The MAGNIFY study explores zervimesine’s potential in slowing lesion growth and addressing retinal degeneration.
Innovative Mechanism of Action
The sigma-2 receptor complex, targeted by zervimesine, regulates key cellular processes such as membrane trafficking and autophagy. These processes are disrupted in neurodegenerative conditions due to toxic protein interactions and oxidative stress. By modulating this receptor, zervimesine aims to normalize synaptic function, protect neurons, and slow disease progression. This mechanism is functionally distinct from other approaches, such as anti-amyloid immunotherapies, positioning Cognition Therapeutics as a pioneer in sigma-2 receptor modulation.
Clinical and Industry Impact
With a strong focus on CNS disorders, Cognition Therapeutics addresses significant unmet needs in Alzheimer’s disease and DLB, which collectively affect millions worldwide. The company’s approach aligns with the growing demand for disease-modifying therapies that go beyond symptomatic relief. Its clinical programs are supported by substantial grant funding from the National Institute on Aging (NIA) and partnerships with leading research institutions.
Challenges and Opportunities
As a clinical-stage company, Cognition Therapeutics faces challenges typical of the biopharmaceutical industry, including high R&D costs, regulatory complexities, and competition from established players. However, its differentiated sigma-2 receptor approach and promising early-phase results provide a strong foundation for future growth. The company’s ability to secure additional funding and advance its pipeline into late-stage trials will be critical to its success.
Conclusion
Cognition Therapeutics Inc. represents a compelling player in the biopharmaceutical sector, leveraging innovative science to address the urgent need for disease-modifying therapies in neurodegenerative disorders. With its lead candidate zervimesine showing promising clinical results, the company is well-positioned to make a meaningful impact on the lives of patients and caregivers affected by Alzheimer’s disease, DLB, and other age-related conditions.
Cognition Therapeutics (Nasdaq: CGTX) has published research in Nature Scientific Reports demonstrating the potential of their drug candidate zervimesine (CT1812) in treating dry age-related macular degeneration (dry AMD).
The research comprised multiple studies, including analysis of cerebrospinal fluid from Alzheimer's disease clinical trials and collaborative in vitro research with the University of Southampton. The studies revealed that zervimesine treatment altered proteins and pathways associated with geographic atrophy and macular degeneration.
Laboratory tests showed that zervimesine could rescue impaired cellular processes in retinal pigment epithelial (RPE) cells, which are important for breaking down photoreceptor debris and maintaining sight. While the results support zervimesine's potential in treating dry AMD, the company will currently focus its financial resources on Alzheimer's disease and dementia with Lewy bodies.
Cognition Therapeutics (NASDAQ: CGTX) announced positive results from the futility analysis of its Phase 2 'MAGNIFY' trial for zervimesine (CT1812) in geographic atrophy (GA) secondary to dry age-related macular degeneration.
The analysis of 57 participants who completed 6 months of dosing revealed that zervimesine-treated patients showed slower lesion growth compared to placebo. The study, which enrolled 100 participants total, will conclude in February 2025, with complete analysis expected in Q2 2025.
Additionally, the company reported successful outcomes in other trials: The Phase 2 SHIMMER study in dementia with Lewy bodies (DLB) met its primary endpoint, with zervimesine showing significant improvements over placebo across multiple measures. The Phase 2 SHINE study in Alzheimer's disease also met its safety endpoint, with a biomarker-defined subgroup showing 95% reduction in cognitive decline versus placebo.
Cognition Therapeutics (NASDAQ: CGTX) announced that Mary Hamby, PhD will co-host a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit on February 25-27, 2025 in Boston.
Dr. Hamby will present findings from Cognition's Phase 2 'SHINE' study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer's disease. The study revealed that participants with lower levels of p-tau217 protein showed significant response to zervimesine treatment, scoring 95% better on the ADAS-Cog 11 scale and 108% better on the MMSE scale compared to placebo.
The workshop, titled "Patient Stratification for Precision Medicine in Neuroscience," will explore how plasma p-tau217 assays could identify Alzheimer's patients most likely to benefit from therapies addressing beta amyloid, including Cognition's oligomer antagonist zervimesine.
Cognition Therapeutics (NASDAQ: CGTX) has published details of a new manufacturing process for their lead Alzheimer's candidate, zervimesine (CT1812), in the American Chemical Society journal Organic Process Research & Development. The company has filed provisional patent applications for both the chemical process and a preferred polymorphic form of the drug.
The new manufacturing process incorporates high throughput screening and light-induced, continuous flow processing technologies, enabling more efficient and safer synthesis of zervimesine. Notably, researchers have identified a novel crystal form of the drug with enhanced room temperature stability, promising a longer shelf life and improved pharmaceutical properties. This process is expected to support both future clinical studies and potential commercial manufacturing needs if the drug receives approval.
Cognition Therapeutics (NASDAQ: CGTX) announced positive Phase 2 'SHIMMER' study results for zervimesine (CT1812) in treating dementia with Lewy bodies (DLB). The study, involving 130 adults with mild-to-moderate DLB over six months, met its primary safety and tolerability endpoints with significant therapeutic improvements.
Key results showed zervimesine-treated participants performed:
- 86% better on behavioral outcomes (NPI A-L)
- 52% better on activities of daily living
- 91% reduction in cognitive fluctuations
- 62% better motor function
The drug demonstrated effectiveness in reducing hallucinations, delusions, anxiety, and agitation - key DLB symptoms. Care partners reported reduced distress levels, and patients showed improved ability to maintain daily living activities. The treatment exhibited a favorable safety profile with mostly mild to moderate adverse events.
Cognition Therapeutics (NASDAQ: CGTX) announced CEO Lisa Ricciardi's participation in upcoming conferences during JP Morgan Healthcare Conference 2025 week. The company reported significant developments in 2024, including positive topline results from their Phase 2 SHIMMER study in dementia with Lewy body (DLB) patients, which will be presented at the International Lewy Body Dementia Conference in Amsterdam.
The company is preparing for an end-of-Phase 2 meeting with the FDA to review results from their SHINE study in mild-to-moderate Alzheimer's disease. Additionally, they received clearance for the generic name 'zervimesine' for their candidate CT1812.
Ricciardi will participate in the Longwood Healthcare Leaders Stanford Summit on January 11, 2025, and the Sachs 8th Annual Neuroscience Innovation Forum on January 12, 2025, both in San Francisco.
Cognition Therapeutics (NASDAQ: CGTX) announced positive topline results from its Phase 2 'SHIMMER' study of CT1812 in dementia with Lewy bodies (DLB). The study, which enrolled 130 patients with mild-to-moderate DLB, met its primary endpoint of safety and tolerability.
Key findings include:
- 82% slowing in total neuropsychiatric inventory with strong reduction in anxiety, hallucinations, and delusions
- Marked reduction in caregiver distress
- 91% decline in fluctuations in attention
- Improvements across behavioral, functional, cognitive, and movement measures
The company plans to advance CT1812 into late-stage trials, with detailed data to be presented at the International Lewy Body Dementia Conference in January 2025.
Cognition Therapeutics (NASDAQ: CGTX) announced the completion of final patient visits in their Phase 2 SHIMMER study evaluating CT1812 for mild-to-moderate dementia with Lewy bodies (DLB). The company expects to report topline results in December 2024. The study was conducted in partnership with the National Institute of Aging and the Lewy Body Dementia Association. The trial aims to assess CT1812's tolerability profile and identify efficacy signals in cognition and function measures for DLB patients.
Cognition Therapeutics (NASDAQ: CGTX) reported new biomarker analysis from their Phase 2 'SHINE' study in mild-to-moderate Alzheimer's disease. The analysis revealed that patients with lower baseline plasma p-tau217 levels treated with CT1812 showed a 95% reduction in cognitive decline compared to placebo, representing a 2.7-point improvement on ADAS-Cog11 over six months. The study demonstrated normalization of key Alzheimer's disease indicators, including reductions in GFAP (neuroinflammatory biomarker), NfL (neurodegenerative biomarker), and impacts on amyloid biology through reductions in Aβ42 and Aβ40 proteins. The company plans to present complete biomarker results at scientific conferences in 2025.
Cognition Therapeutics (NASDAQ: CGTX) reported significant results from its Phase 2 SHINE study, showing CT1812 slowed cognitive decline by 95% in Alzheimer's patients with lower p-tau217 levels. The company expects to report topline results from Phase 2 SHIMMER study in DLB patients by end of 2024. Financial results show cash position of $22.0 million as of September 30, 2024, with additional $53.6 million in NIA grant funds. Q3 2024 resulted in a net loss of $9.9 million, or $(0.25) per share, compared to $6.7 million loss in Q3 2023. R&D expenses were $11.4 million, slightly down from $11.7 million in the previous year.
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