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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 completed enrollment for its Phase 2 SEQUEL study (COG0202) involving 16 adults with mild-to-moderate Alzheimer’s disease. This randomized, double-blind study aims to investigate the effects of CT1812 using quantitative electroencephalogram (qEEG) to measure changes in theta wave activity, which is linked to memory and information processing. Topline results are expected in mid-2023. The study is supported by a $5.3 million grant from the National Institute of Aging. CT1812 targets sigma-2 receptors to disrupt Aβ oligomers, potentially offering a novel approach to treat Alzheimer's disease.
Cognition Therapeutics (CGTX) recently released its second "Conversations" video podcast featuring experts discussing clinical data from the 2022 CTAD conference. The episode, moderated by Anthony Caggiano, M.D., focuses on insights from the lecanemab CLARITY study, emphasizing the importance of targeting amyloid oligomers for Alzheimer’s treatment. Cognition is advancing its lead candidate CT1812, targeting Alzheimer’s and related disorders, highlighting the necessity of innovative therapeutic approaches in neurodegenerative disease management.
Cognition Therapeutics, Inc. (Nasdaq: CGTX) announced participation in the 6th Annual Sachs Neuroscience Forum, Biotech Showcase, and BIO Partnering at JPM, taking place alongside the J.P. Morgan Annual Healthcare Conference 2023.
The events will feature panel discussions and corporate presentations on Alzheimer's and cognitive disorders, scheduled for January 8-9, 2023, in San Francisco, CA. The Cognition management team will meet with investors and pharmaceutical companies to discuss corporate achievements and clinical development strategies.
Cognition Therapeutics announced the expansion of its Phase 2 SHINE clinical trial for CT1812, an experimental Alzheimer's treatment, to include sites in Spain, the Netherlands, and the Czech Republic, in addition to the USA. The trial aims to enroll 144 participants and investigates CT1812's ability to prevent synaptotoxic effects caused by oligomers. Initial trials indicate potential cognition improvements and brain volume preservation. The study receives approximately $30 million in grant funding from the National Institutes on Aging.
Cognition Therapeutics (Nasdaq: CGTX) announced significant advancements regarding its Phase 2 trial for CT1812, targeting geographic atrophy due to dry age-related macular degeneration (dry AMD). With dry AMD affecting 10 million people in the U.S., the company emphasizes the need for effective treatments. CT1812, an oral sigma-2 receptor modulator, has shown promise in preclinical studies, demonstrating potential to rescue retinal pigment epithelial (RPE) functions impaired by oxidative stress. Cognition is in discussions with the FDA to initiate trials involving over 200 participants.
Cognition Therapeutics has announced the activation of up to 30 sites across the USA for its ongoing SHIMMER clinical trial evaluating CT1812, a novel treatment for dementia with Lewy bodies (DLB). This Phase 2 study aims to assess the safety and efficacy of CT1812, enrolling around 120 adults over six months. DLB currently lacks approved treatments, affecting approximately 1.4 million people in the U.S. The trial is supported by a $30 million grant from the National Institute on Aging and aims to provide crucial insights into cognitive and physical activity changes in DLB patients.
Cognition Therapeutics, Inc. (Nasdaq: CGTX) recently completed its public offering, closing the sale of 5 million shares at $1.20 each, raising approximately $6 million in gross proceeds. The offering included a 30-day option for underwriters to purchase an additional 750,000 shares. The funds will support the development of its product candidates and general corporate purposes. Cantor Fitzgerald & Co. served as the sole book-running manager. This transaction is expected to enhance Cognition's financial position as it advances its clinical programs targeting Alzheimer's disease and related disorders.
Cognition Therapeutics (Nasdaq: CGTX) reported Q3 2022 financial results, showing a net loss of $6.6 million, or $0.29 per share, compared to a loss of $4.9 million in Q3 2021. The company continues to advance Phase 2 trials for CT1812, with enrollment for the SHINE study expanding into Europe. The SEQUEL trial received a $2.14M NIA grant to support enrollment completion. R&D expenses increased to $8.3 million due to trial activity, while general and administrative expenses rose to $4.4 million. Cash and equivalents stood at $46.6 million as of September 30, with $93.6 million in grants available.
Cognition Therapeutics, Inc. (Nasdaq: CGTX) announced a public offering of 5,000,000 shares of common stock at $1.20 each, aiming for gross proceeds of approximately $6.0 million. The offering is set to close on November 15, 2022, pending customary conditions. Proceeds will fund the development of its product candidates and general corporate purposes. Cantor Fitzgerald & Co. is the sole book-running manager, with Newbridge Securities Corporation as co-manager. The SEC declared the registration statement effective on November 9, 2022.
Cognition Therapeutics, Inc. (Nasdaq: CGTX) is recruiting participants for the SHIMMER Phase 2 clinical trial of CT1812, aimed at treating Lewy Body Dementia (LBD), with over 1.4 million Americans affected. This trial will include 120 adults aged 50 to 80 and analyze cognitive and physical changes over six months. Supported by $30M in NIH grants, the study is crucial given the lack of approved treatments for LBD. The company aims to raise awareness about this often-misdiagnosed condition during Lewy Body Dementia Awareness Month.
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