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Business Upturn
17-07-2025
- Health
- Business Upturn
Dementia Associated with Alzheimer's Disease Drug Development Surges with 180+ Companies Pushing New Therapeutic Frontiers
By GlobeNewswire Published on July 17, 2025, 22:00 IST New York, USA, July 17, 2025 (GLOBE NEWSWIRE) — Dementia Associated with Alzheimer's Disease Drug Development Surges with 180+ Companies Pushing New Therapeutic Frontiers | DelveInsight Dementia associated with Alzheimer's disease is a progressive neurodegenerative condition characterized by memory loss, cognitive decline, and impaired daily functioning. The growing aging population worldwide is leading to a rising prevalence of Alzheimer's-related dementia, fueling demand for effective diagnostics and disease-modifying therapies. DelveInsight's 'Dementia Associated with Alzheimer's Disease Pipeline Insight 2025' report provides comprehensive global coverage of pipeline dementia associated with Alzheimer's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the dementia associated with Alzheimer's disease pipeline domain. Key Takeaways from the Dementia Associated with Alzheimer's Disease Pipeline Report DelveInsight's dementia associated with Alzheimer's disease pipeline report depicts a robust space with 180+ active players working to develop 200+ pipeline dementia associated with Alzheimer's disease drugs. active players working to develop pipeline dementia associated with Alzheimer's disease drugs. Key dementia associated with Alzheimer's disease companies such as BioVie, Bristol Myers Squibb, Cognition Therapeutics, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Cognition Therapeutics, AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Amylyx Pharmaceuticals Inc. , Merry Life Biomedical Company , Praxis Bioresearch, Alector, Inc., Galimedix, MIRAMOON Pharma, NervGen Pharma, Psy Therapeutics, NW PharmaTech, PerioTrap Pharmaceuticals, ADEL, Inc., TauRx Therapeutics Ltd, Eli Lilly and Company, Suven Life Sciences, AB Science, Neurim Pharmaceuticals, Merck Sharp & Dohme, Novartis, Priavoid, Pharmazz, Partner Therapeutics, UCB Biopharma, Longeveron Inc., and others are evaluating new dementia associated with Alzheimer's disease drugs to improve the treatment landscape. and others are evaluating new dementia associated with Alzheimer's disease drugs to improve the treatment landscape. Promising pipeline dementia associated with Alzheimer's disease therapies, such as Bezisterim KarXT, CT-1812, TB 006, CM383, ALZ 101, AR1001, CT1812, ABBV-916, ALX-001, E2814, VT301, AMX0035, TML-6, PRX-P4-003, ADP037-ABC, GAL-201, MP-010, NVG 300, PSY-02, EMCBD-1, S-636, ADEL-Y07, TRx0237, Remternetug, Masupirdine, Masitinib, Piromelatine, MK-1167, Siponimod, PRI-002, PMZ-1620, Sargramostim, Bepranemab, Lomecel-B, and others, are in different phases of Dementia Associated with Alzheimer's Disease clinical trials. and others, are in different phases of Dementia Associated with Alzheimer's Disease clinical trials. In May 2025, Nuravax Inc. was awarded a USD 3 million grant from the National Institutes of Health (NIH) to support Duvax, the first dual-target Alzheimer's vaccine, in its entry into human clinical trials. was awarded a USD 3 million grant from the National Institutes of Health (NIH) to support Duvax, the first dual-target Alzheimer's vaccine, in its entry into human clinical trials. In February 2025, NKGen Biotech, Inc . announced that the US Food and Drug Administration had granted Fast Track designation for the investigation of troculeucel, ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer's disease. . announced that the US Food and Drug Administration had granted Fast Track designation for the investigation of troculeucel, ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer's disease. In February 2025, Swedish pharmaceutical company AlzeCure Pharma secured a Eur 2.5m (USD 2.62m) grant from the EU's European Innovation Council (EIC) to support a Phase IIa trial of NeuroRestore ACD856 for Alzheimer's disease. Swedish pharmaceutical company AlzeCure Pharma secured a Eur 2.5m (USD 2.62m) grant from the EU's European Innovation Council (EIC) to support a Phase IIa trial of NeuroRestore ACD856 for Alzheimer's disease. In April 2025, Biogen announced that the US Food and Drug Administration had granted Fast Track designation to BIIB080 , an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease. announced that the US Food and Drug Administration had granted Fast Track designation to , an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease. In March 2025, Longeveron Inc. announced the positive outcome of a Type B meeting with the US Food and Drug Administration, supporting the advancement of laromestrocel (Lomecel-BTM), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzheimer's disease. The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase II/III clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel (Lomecel-BTM) dose selection and frequency, trial duration, and trial endpoints. To accelerate the pathway to potential approval, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study. announced the positive outcome of a Type B meeting with the US Food and Drug Administration, supporting the advancement of laromestrocel (Lomecel-BTM), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzheimer's disease. The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase II/III clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel (Lomecel-BTM) dose selection and frequency, trial duration, and trial endpoints. To accelerate the pathway to potential approval, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study. In February 2025, Neuphoria Therapeutics announced that the company was due to receive a USD 15 million milestone payment from Merck, known as MSD outside the United States and Canada. The payment was triggered by the initiation, by Merck, of a Phase II clinical trial to evaluate the safety and efficacy of MK-1167, an α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM), for the treatment of the symptoms of Alzheimer's disease dementia. announced that the company was due to receive a USD 15 million milestone payment from Merck, known as MSD outside the United States and Canada. The payment was triggered by the initiation, by Merck, of a Phase II clinical trial to evaluate the safety and efficacy of MK-1167, an α7 nicotinic acetylcholine receptor positive allosteric modulator (PAM), for the treatment of the symptoms of Alzheimer's disease dementia. In February 2025, NKGen Biotech announced that the US Food and Drug Administration has granted Fast Track designation for the investigation of troculeucel , ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer's disease. announced that the US Food and Drug Administration has granted Fast Track designation for the investigation of , ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer's disease. In February 2025, NeuroTherapia, Inc., a clinical-stage company focused on developing oral therapies for neurodegenerative diseases, announced it had received approval for its Phase II clinical trial from the European Medicines Agency (EMA). NTRX-07, the company's lead molecule, will be administered to Alzheimer's disease (AD) participants for 28 days in this double-masked, randomized clinical trial. In addition to monitoring safety, pharmacokinetics, and standard measures of clinical efficacy (ADAS-cog, MMSA, and Trails Making Test), the trial is also designed to give an indication of target engagement by analyzing various biomarkers of neuroinflammation and neuronal function. a clinical-stage company focused on developing oral therapies for neurodegenerative diseases, announced it had received approval for its Phase II clinical trial from the European Medicines Agency (EMA). NTRX-07, the company's lead molecule, will be administered to Alzheimer's disease (AD) participants for 28 days in this double-masked, randomized clinical trial. In addition to monitoring safety, pharmacokinetics, and standard measures of clinical efficacy (ADAS-cog, MMSA, and Trails Making Test), the trial is also designed to give an indication of target engagement by analyzing various biomarkers of neuroinflammation and neuronal function. In January 2025, the US FDA granted Fast Track designation to Posdinemab , a phosphorylated tau-directed monoclonal antibody (mAb) being investigated to treat patients with early Alzheimer's disease. the US FDA granted Fast Track designation to , a phosphorylated tau-directed monoclonal antibody (mAb) being investigated to treat patients with early Alzheimer's disease. In November 2024 , Alector announced results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer's disease (AD). , announced results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer's disease (AD). In October 2024, Hoth Therapeutics, Inc. announced the granting of a US patent for its pioneering Alzheimer's treatment, HT-ALZ. Request a sample and discover the recent advances in dementia associated with Alzheimer's disease drugs @ Dementia Associated with Alzheimer's Disease Pipeline Report The dementia associated with Alzheimer's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dementia associated with Alzheimer's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dementia associated with Alzheimer's disease clinical trial landscape. Dementia Associated with Alzheimer's Disease Overview Dementia is a broad term that refers to a marked decline in cognitive abilities that affects a person's daily functioning. Alzheimer's disease (AD) is the most common form of dementia, responsible for at least two-thirds of cases in people aged 65 and older. AD is a progressive neurodegenerative disorder that begins gradually and leads to worsening impairments in behavior and cognitive skills such as memory, understanding, language, attention, reasoning, and judgment. Although Alzheimer's itself is not directly fatal, it greatly increases the risk of other complications that can ultimately result in death. The diagnosis of Alzheimer's-related dementia usually requires a thorough evaluation, including medical history, cognitive assessments, physical and neurological exams, and sometimes brain imaging. Physicians first exclude other possible causes of cognitive decline, like vitamin deficiencies or thyroid issues. Cognitive tests evaluate memory, problem-solving, and language to identify patterns indicative of Alzheimer's. Brain scans, such as MRI or CT, help detect structural changes like brain shrinkage. More advanced diagnostic tools, including PET scans or cerebrospinal fluid tests, can reveal specific biomarkers linked to Alzheimer's, offering stronger confirmation. Currently, there is no cure for Alzheimer's disease since brain cell loss cannot be reversed. However, treatments are available to ease symptoms and enhance the quality of life for patients and their caregivers. Cholinesterase inhibitors are medications that help reduce cognitive symptoms such as memory problems, confusion, and impaired judgment by improving communication between brain cells and slowing symptom progression. The three FDA-approved drugs commonly used for Alzheimer's treatment include donepezil (Aricept) for all stages, and galantamine (Razadyne) and rivastigmine (Exelon) for mild to moderate stages. Find out more about dementia associated with Alzheimer's disease drugs @ Dementia Associated with Alzheimer's Disease Treatment A snapshot of the Pipeline Dementia Associated with Alzheimer's Disease Drugs mentioned in the report: Drugs Company Phase MoA RoA Bezisterim (NE3107) BioVie III NF-kappa B inhibitor; Tumour necrosis factor inhibitor Oral KarXT Bristol Myers Squibb III Muscarinic M1 receptor agonists; Muscarinic M4 receptor agonists; Muscarinic receptor antagonists Oral Buntanetap Annovis Bio III Alpha-synuclein inhibitors; Amyloid beta-protein precursor inhibitors; HD protein inhibitors; Tau protein inhibitors Oral AR1001 AriBio III Type 5 cyclic nucleotide phosphodiesterase inhibitors Oral CT-1812 Cognition Therapeutics II Sigma-2 receptor antagonists Oral TW001 Treeway B.V. II Antioxidants; Free radical scavengers Oral AMX0035 Amylyx Pharmaceuticals II Ammonia scavenger; Histone deacetylase inhibitor; Phosphotransferase inhibitor Oral CM383 KeyMed Biosciences I Amyloid beta-protein inhibitors Intravenous Learn more about the emerging dementia associated with Alzheimer's disease therapies @ Dementia Associated with Alzheimer's Disease Clinical Trials Dementia Associated with Alzheimer's Disease Therapeutics Assessment The dementia associated with Alzheimer's disease pipeline report proffers an integral view of the emerging dementia associated with Alzheimer's disease therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action. Scope of the Dementia Associated with Alzheimer's Disease Pipeline Report Coverage : Global : Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action : Adiponectin stimulants, Interleukin 23 inhibitors, Interleukin 6 inhibitors, Mitogen-activated protein kinase 1 inhibitors, Mitogen-activated protein kinase 3 inhibitors, NF-kappa B inhibitors, Tumour necrosis factor inhibitors, Muscarinic M1 receptor agonists, Muscarinic M4 receptor agonists, Muscarinic receptor antagonists, Microfilament protein modulators, Sigma-2 receptor antagonists, Amyloid beta-protein inhibitors, TREM2 protein-stimulants, Type 5 cyclic nucleotide phosphodiesterase inhibitors, Ammonia scavengers, Histone deacetylase inhibitors, Phosphotransferase inhibitors : Adiponectin stimulants, Interleukin 23 inhibitors, Interleukin 6 inhibitors, Mitogen-activated protein kinase 1 inhibitors, Mitogen-activated protein kinase 3 inhibitors, NF-kappa B inhibitors, Tumour necrosis factor inhibitors, Muscarinic M1 receptor agonists, Muscarinic M4 receptor agonists, Muscarinic receptor antagonists, Microfilament protein modulators, Sigma-2 receptor antagonists, Amyloid beta-protein inhibitors, TREM2 protein-stimulants, Type 5 cyclic nucleotide phosphodiesterase inhibitors, Ammonia scavengers, Histone deacetylase inhibitors, Phosphotransferase inhibitors Key Dementia Associated with Alzheimer's Disease Companies : BioVie, Bristol Myers Squibb, Cognition Therapeutics, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Cognition Therapeutics, AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Amylyx Pharmaceuticals Inc., Merry Life Biomedical Company, Praxis Bioresearch, Alector, Inc., Galimedix, MIRAMOON Pharma, NervGen Pharma, Psy Therapeutics, NW PharmaTech, PerioTrap Pharmaceuticals, ADEL, Inc., TauRx Therapeutics Ltd, Eli Lilly and Company, Suven Life Sciences, AB Science, Neurim Pharmaceuticals, Merck Sharp & Dohme, Novartis, Priavoid, Pharmazz, Partner Therapeutics, UCB Biopharma, Longeveron Inc., and others. : BioVie, Bristol Myers Squibb, Cognition Therapeutics, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Cognition Therapeutics, AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Amylyx Pharmaceuticals Inc., Merry Life Biomedical Company, Praxis Bioresearch, Alector, Inc., Galimedix, MIRAMOON Pharma, NervGen Pharma, Psy Therapeutics, NW PharmaTech, PerioTrap Pharmaceuticals, ADEL, Inc., TauRx Therapeutics Ltd, Eli Lilly and Company, Suven Life Sciences, AB Science, Neurim Pharmaceuticals, Merck Sharp & Dohme, Novartis, Priavoid, Pharmazz, Partner Therapeutics, UCB Biopharma, Longeveron Inc., and others. Key Dementia Associated with Alzheimer's Disease Pipeline Therapies: Bezisterim KarXT, CT-1812, TB 006, CM383, ALZ 101, AR1001, CT1812, ABBV-916, ALX-001, E2814, VT301, AMX0035, TML-6, PRX-P4-003, ADP037-ABC, GAL-201, MP-010, NVG 300, PSY-02, EMCBD-1, S-636, ADEL-Y07, TRx0237, Remternetug, Masupirdine, Masitinib, Piromelatine, MK-1167, Siponimod, PRI-002, PMZ-1620, Sargramostim, Bepranemab, Lomecel-B, and others. Dive deep into rich insights for new dementia associated with Alzheimer's disease treatments, visit @ Dementia Associated with Alzheimer's Disease Drugs Table of Contents 1. Dementia Associated with Alzheimer's Disease Pipeline Report Introduction 2. Dementia Associated with Alzheimer's Disease Pipeline Report Executive Summary 3. Dementia Associated with Alzheimer's Disease Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Dementia Associated with Alzheimer's Disease Clinical Trial Therapeutics 6. Dementia Associated with Alzheimer's Disease Pipeline: Late-Stage Products (Pre-registration) 7. Dementia Associated with Alzheimer's Disease Pipeline: Late-Stage Products (Phase III) 8. Dementia Associated with Alzheimer's Disease Pipeline: Mid-Stage Products (Phase II) 9. Dementia Associated with Alzheimer's Disease Pipeline: Early-Stage Products (Phase I) 10. Dementia Associated with Alzheimer's Disease Pipeline Therapeutics Assessment 11. Inactive Products in the Dementia Associated with Alzheimer's Disease Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the Dementia Associated with Alzheimer's Disease Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix For further information on the dementia associated with Alzheimer's disease pipeline therapeutics, reach out @ Dementia Associated with Alzheimer's Disease Therapeutics Related Reports Alzheimer's Disease Epidemiology Alzheimer's Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted Alzheimer's disease epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including BioVie, AB Science, Cassava Sciences, TauRx Therapeutics, Novo Nordisk, KeifeRx, Eli Lilly, AriBio, Cerecin, Alzheon, Neurim Pharmaceuticals, Syneos Health, Athira Pharma, Annovis Bio, Anavex Life Sciences, AgeneBio, Eisai, among others. Agitation in Alzheimer's Disease Market Agitation in Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key agitation in Alzheimer's disease companies, including Eli Lilly and Co, BioVie Inc., AB Science SA, Annovis Bio Inc., Cognition Therapeutics Inc., Coya Therapeutics Inc., Actinogen Medical Limited, AC Immune SA, Biogen Inc., Longeveron Inc., among others. Psychosis in Parkinson's and Alzheimer's Disease Market Psychosis in Parkinson's and Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis in Parkinson's and Alzheimer's disease companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, among others. Alzheimer's Disease Diagnostic Market Alzheimer's Disease Diagnostic Market Insights, Competitive Landscape and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key Alzheimer's disease diagnostic companies, including F. Hoffmann-La Roche Ltd., General Electric Company, 23andMe, Inc., Lilly, Fujirebio, Siemens Medical Solutions USA, Inc., Diadem srl., Todos Medical, DISCERN™, FUJIFILM Holdings America Corporation, Koninklijke Philips N.V., CANON MEDICAL SYSTEMS EUROPE B.V., Shimzadu Corporation., Laboratory Corporation of America® Holdings, Bruker, Magnetica., IMRIS, Deerfield Imaging, Inc., MR Solutions, Hyperfine, Inc., Neusoft Corporation, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. 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Yahoo
16-07-2025
- Health
- Yahoo
Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC
- 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 - PURCHASE, N.Y., July 16, 2025 (GLOBE NEWSWIRE) -- 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. Cognition at AAIC: 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 About the SHIMMER Study in Dementia with Lewy BodiesThe 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, 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 Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our future clinical development plans, and statements regarding our clinical trials of zervimesine and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'seek,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'forecast,' 'potential' or 'continue' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the 'Risk Factors' section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Casey McDonald (media)Tiberend Strategic Advisors, Mike Moyer (investors)LifeSci Advisorsmmoyer@ This press release was published by a CLEAR® Verified individual.
Yahoo
12-07-2025
- Business
- Yahoo
Cognition Therapeutics, Inc. (CGTX) Retains Buy Rating on START Study Progress
Cognition Therapeutics, Inc. (NASDAQ:CGTX) is among the . H.C. Wainwright has maintained a $3.00 price target for Cognition Therapeutics, Inc. (NASDAQ:CGTX), with an unchanged Buy rating. This potential upside of nearly 640% represents the company's Phase 2 START Study enrollment success that exceeded 50%. The START Study (NCT05531656), which is examining ervimesine (CT1812) in patients living with mild Alzheimer's disease, is being conducted in partnership with the Alzheimer's Clinical Trials Consortium (ACTC). The expected participants, with 540 individuals across approximately 50 sites, will receive either the drug or placebo for 18 months. A laboratory setup with technicians in lab coats working in a biotech facility. With around $81 million in grant support from the National Institute of Aging (NIA), a segment of the National Institutes of Health, Cognition Therapeutics, Inc. (NASDAQ:CGTX) has the necessary support to lead the study. The firm further outlines the clinical potential of zervimesine as the company accelerates the pace for a Phase 3 program. Cognition Therapeutics, Inc. (NASDAQ:CGTX), based in New York, is a clinical-stage biopharmaceutical company that identifies and develops small molecule therapeutics aimed at age-related degenerative diseases and disorders of the central nervous system and retina. Incorporated in 2007, the company is committed to improving the lives of many. While we acknowledge the potential of CGTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11-07-2025
- Business
- Yahoo
Cognition Therapeutics, Inc. (CGTX) Retains Buy Rating on START Study Progress
Cognition Therapeutics, Inc. (NASDAQ:CGTX) is among the . H.C. Wainwright has maintained a $3.00 price target for Cognition Therapeutics, Inc. (NASDAQ:CGTX), with an unchanged Buy rating. This potential upside of nearly 640% represents the company's Phase 2 START Study enrollment success that exceeded 50%. The START Study (NCT05531656), which is examining ervimesine (CT1812) in patients living with mild Alzheimer's disease, is being conducted in partnership with the Alzheimer's Clinical Trials Consortium (ACTC). The expected participants, with 540 individuals across approximately 50 sites, will receive either the drug or placebo for 18 months. A laboratory setup with technicians in lab coats working in a biotech facility. With around $81 million in grant support from the National Institute of Aging (NIA), a segment of the National Institutes of Health, Cognition Therapeutics, Inc. (NASDAQ:CGTX) has the necessary support to lead the study. The firm further outlines the clinical potential of zervimesine as the company accelerates the pace for a Phase 3 program. Cognition Therapeutics, Inc. (NASDAQ:CGTX), based in New York, is a clinical-stage biopharmaceutical company that identifies and develops small molecule therapeutics aimed at age-related degenerative diseases and disorders of the central nervous system and retina. Incorporated in 2007, the company is committed to improving the lives of many. While we acknowledge the potential of CGTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-05-2025
- Health
- Yahoo
Cognition announces outcomes from trial of zervimesine for geographic atrophy
Cognition Therapeutics has announced positive topline outcomes from the double-masked Phase II MAGNIFY trial of zervimesine (CT1812) in adult patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The placebo-controlled study was completed following the enrolment of approximately 100 of the planned 246 subjects. It used two measures to assess the change in GA lesions: growth rate and size. Subjects were evaluated for tolerability and safety, GA lesion size and growth rate changes, visual acuity changes, and other visual and anatomic measures. According to the company, a slope analysis indicated that the GA trajectory had slowed by 28.6% in patients treated with zervimesine. In addition, at 18 months, the mean lesion size for those treated with zervimesine was 28.2% smaller than that of the placebo group. Nearly two-thirds of subjects completed one year of dosing, and one-third completed 18 months. While additional data on demographics, safety, and visual and anatomic outcomes are still under analysis, the company plans to present the complete findings at a medical meeting later in the year. GA is marked by the formation of lesions consisting of dead retinal cells and undegraded waste proteins, leading to central vision blind spots. In the trial, subjects were randomised and were given either a placebo or 200mg of oral zervimesine once a day. The voluntary conclusion of the study enabled Cognition to redirect resources towards its ongoing Alzheimer's and dementia with lewy bodies (DLB) programmes. Cognition Therapeutics research and development head and chief medical officer Anthony Caggiano said: 'To date, we have observed evidence of robust slowing of disease progression with zervimesine treatment in Phase II studies in Alzheimer's disease and dementia with Lewy bodies. 'These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill. Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.' In April last year, the company completed subject enrolment in its Phase II SHIMMER trial of CT1812 for treating mild-to-moderate DLB. "Cognition announces outcomes from trial of zervimesine for geographic atrophy" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
