Elayta (zervimesine) / Cognition Therap - LARVOL DELTA

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 (GlobeNewswire) - "Cognition Therapeutics...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....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....Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer’s study at AAIC."

P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Completes End-of-Phase 2 Meeting with FDA for Zervimesine (CT1812) in Alzheimer’s Disease (GlobeNewswire) - "Cognition Therapeutics, Inc...conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine as a treatment for Alzheimer’s disease...'We discussed the results from the Phase 2 ‘SHINE’ Study in Alzheimer’s disease and our proposed Phase 3 plan with the FDA and believe we have a path forward for the development of zervimesine in the treatment of Alzheimer’s disease. We look forward to reviewing the FDA’s formal minutes in August to confirm our path forward.'"

FDA event • Alzheimer's Disease

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Surpasses 50% Enrollment Target (GlobeNewswire) - "Cognition Therapeutics...announced that the Phase 2 ‘START’ Study surpasses 50% enrollment....The START Study (NCT05531656) is designed to enroll up to 540 individuals with mild Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for 18 months. Participants are being enrolled at approximately 50 sites in the United States, including premier institutions in the ACTC network."

Enrollment status • Alzheimer's Disease

Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB) (GlobeNewswire) - "Cognition Therapeutics, Inc...announced that the company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. During the meeting, the Cognition team will review results of the Phase 2 'SHINE’ study (NCT03507790) of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease. In addition, proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population will be discussed with the FDA."

Clinical protocol • FDA event • P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Identification of cerebrospinal fluid pharmacodynamic biomarkers and molecular correlates of brain activity in a Phase 2 clinical trial of the Alzheimer's disease drug candidate CT1812. (PubMed, Alzheimers Dement (N Y)) - P2 | "After 1 month of treatment, the identification of biomarkers supporting pathway engagement, the replication of biomarker findings from prior trials, and the discovery of molecular correlates of improved functional connectivity with CT1812 treatment bolster support for and expound upon the mechanism of action for CT1812 in displacing Aβ oligomers at neuronal synapses, as well as underscores the CT1812 relevance to AD."

Biomarker • Journal • P2 data • PK/PD data • Alzheimer's Disease • CNS Disorders

A Review of the Clinical Progress of CT1812, a Novel Sigma-2 Receptor Antagonist for the Treatment of Alzheimer's Disease. (PubMed, Pharmaceuticals (Basel)) - "Preclinical studies and early clinical trials of CT1812 show promising results and provide evidence for its potential to slow AD progression. This review outlines the role of Aβ oligomers in AD, CT1812's mechanism of action, and the effectiveness and limitations of CT1812 based on preclinical and clinical studies."

Journal • Review • Alzheimer's Disease • CNS Disorders

Cognition Therapeutics Presented Data at Association for Research in Vision and Ophthalmology Showing Impact on Retinal Cell Health (GlobeNewswire) - "Cognition Therapeutics, Inc...reported preclinical data this week at the Association for Research in Vision and Ophthalmology (ARVO) showing the potential for zervimesine (CT1812) to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD)....A poster presented by research scientist, Britney Lizama, PhD, shows that this receptor regulates the ability of retinal cells to take in low-density lipoprotein (LDL), a major fuel source for cells....A second poster presented by Drs. Hamby and Lizama, shows zervimesine may protect retinal cells from the onslaught of oxidized lipids. In dry AMD, oxidized lipids build up in the retina."

Preclinical • Dry Age-related Macular Degeneration

Cognition Therapeutics Reports Topline Results Showing Oral Zervimesine (CT1812) Reduced Lesion Growth in Phase 2 Study in Geographic Atrophy (GlobeNewswire) - P2 | N=100 | MAGNIFY (NCT05893537) | Sponsor: Cognition Therapeutics | "Cognition Therapeutics... reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The results show zervimesine-treated participants had 28.6% slower GA lesion growth on average and at 18 months, their lesions were 28.2% smaller compared to placebo. The MAGNIFY study (NCT05893537) was concluded, after approximately 100 of the planned 246 participants were enrolled....Growth rate: in MAGNIFY, a slope analysis showed that the trajectory of GA had slowed by 28.6% in participants treated with zervimesine."

P2 data • Dry Age-related Macular Degeneration • Ophthalmology

Expanded Access Program for CT1812 (Zervimesine) (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Cognition Therapeutics

New trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Cognition Therapeutics Reports Financial Results for the First Quarter 2025 and Provides Business Update (GlobeNewswire) - "Requested an EOP2 meeting with FDA to review the results from the SHINE study in Alzheimer’s disease. Phase 2 ‘SHIMMER’ study results in DLB were accepted for a podium presentation at the Alzheimer’s Association International Congress (AAIC), to be held July 27-31, 2025 in Toronto, Canada."

FDA event • P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

MAGNIFY: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD). (clinicaltrials.gov) - P2 | N=100 | Terminated | Sponsor: Cognition Therapeutics | Active, not recruiting ➔ Terminated; The trial was closed as part of a strategic business decision.

Trial termination • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

IDENTIFICATION OF MOLECULAR CORRELATES WITH CT1812 TREATMENT -RELATED DECREASE IN NFL CSF LEVELS CONNECTED TO SIGMA -2 2RECEPTOR (ADPD 2025) - "Molecular correlates relevant to neurodegeneration were identified with CSF NfL levels after treatment with CT1812. Of note NEFL can interact with prion protein (PRNP), which is a component of the S2R complex. This analysis enabled additional learnings on what other changes may occur in tandem with the decrease in NfL."

Alzheimer's Disease • CNS Disorders • CSF NfL • FABP3 • NEFL • PRNP • S100B

IDENTIFICATION OF CSF PROTEINS THAT CORRELATE WITH COGNITIVE OUTCOMES IN PARTICIPANTS OF PHASE 2 STUDY SHINE EVALUATING EFFECTS OF CT1812 IN PATIENTS WITH ALZHEIMER'S DISEASE (ADPD 2025) - P2 | "CT1812 PD biomarkers that correlated with favorable ADAS -Cog11 change were identified. Correlation analysis results were consistent with the impact of CT1812 on synaptic protection and mechanisms in amyloid biology. These exploratory biomarker analyses, to gether with CT1812 -associated trends in slowing cognitive decline, particularly in a pre -specified p -Tau217 subgroup, support the clinical developme nt of CT1812 for AD."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • APOE • PRNP

CSF PROTEOMIC BIOMARKER ANALYSIS FROM PHASE 2 STUDY SHINE IDENTIFIED EFFECTS OF S2R MODULATOR CT1812 IN ALZHEIMER'S DISEASE (ADPD 2025) - P2 | "CSF proteomic analysis of the completed SHINE trial corroborated previously identified biomarkers of CT1812 pathway engagement and disease modification and facilitated identification of novel biomarkers. These data further our understanding of the proteins and pathways CT1812 impacts and help support the observed synaptoprotective mechanism -of-action and continued clinical development of CT1812 for AD."

Biomarker • P2 data • Alzheimer's Disease • CNS Disorders • CLU

TREATMENT OF DLB AND PDD: STATUS AND NEW DEVELOPMENTS (ADPD 2025) - "There is however, Level 1 evidence for the use of cholinesterase inhibitors and mixed evidence for memantine for cognition in both conditions,, and for zonisamide for parkinsonism in DLB...Examples of drugs in ongoing trials based on ClinicalTrials.Gov are neflampimod, CT1812, and ambroxol, and memantine as add-on to cholinesterase inhibitor...There are currently no widely accepted DLB-specific outcome measures available, but development of such instruments is ongoing. These and other design elements will be discussed."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry

POSITIVE IMPACT OF CT1812 TREATMENT ON PLASMA BIOMARKERS IN LOWER P-TAU217 SUBGROUP ALIGNS WITH CLINICAL BENEFITS IN MILD TO MODERATE AD PATIENTS (ADPD 2025) - P2 | "Conclusions Plasma biomarker findings revealed favorable treatment effects in the lower p-Tau217 subgroup with CT1812 treatment. Paired with the greater treatment benefits observed on cognitive measures in the lower p-Tau217 subgroup, these data support the hypothesis that CT1812 has a more beneficial impact in AD patients with less AD pathology."

Biomarker • Clinical • Aβ42 • GFAP • Plasma Aβ40

Sigma-2 Receptor Modulation Promotes Retinal Pigmented Epithelial Cell Survival Following Chronic 7-Ketocholesterol Exposure (ARVO 2025) - "Treatment with S2R modulator CT2074 significantly increased the number of adherent viable cells in 7KC-treated cultures compared to cells treated with 7KC alone (100μM 7KC: 44% ± 14.8 SEM viable cells + CT2074 vs 25% ±16.5 SEM +Vehicle; n=3 experiments, p<0.05 two-way ANOVA)...Ongoing studies using the chronic 7KC in vitro model are underway to test the protective capacity of additional S2R modulators, including the investigational therapeutic CT1812 that is being tested in a Phase 2 clinical trial for geographic atrophy secondary to dry AMD. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Delineating Mechanisms of Sigma-2 Receptor Modulators in Regulating Retinal Pigmented Epithelial Lipid Uptake (ARVO 2025) - "To assess effects of S2R modulation, cells were treated with vehicle or S2R modulators (CT1812, CT2074, CT2168) for 16 hrs prior to and during LDL-DyL. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • LDLR • VCL

Cognition Therapeutics to Report Biomarker Results from Phase 2 SHINE Study in Mild-to-Moderate Alzheimer’s Disease in Podium Presentation at AD/PD 2025 (GlobeNewswire) - "Cognition Therapeutics, Inc...will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at the AD/PD 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria."

Biomarker • P2 data • Alzheimer's Disease

MAGNIFY: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants with Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD). (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Cognition Therapeutics | Trial completion date: Aug 2027 ➔ Mar 2025 | Trial primary completion date: Jul 2027 ➔ Mar 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Next steps for zervimesine include end-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) to align on plans for Phase 3 clinical protocols for both indications. The company plans to request separate end-of-Phase 2 meetings for Alzheimer’s disease and DLB. That process is expected to start in early second quarter of 2025."

FDA event • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics to Present at Life Sciences Virtual Investor Conference (GlobeNewswire) - "Cognition Therapeutics, Inc...announced that President and CEO Lisa Ricciardi will present live at the Life Sciences Virtual Investor Conference on March 13, 2025 at 9:30 a.m. ET. In her presentation, Ms. Ricciardi will review plans for 2025 to support the advancement of zervimesine (CT1812) in Alzheimer’s disease and dementia with Lewy bodies following the Company’s positive Phase 2 data readouts."

P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Publishes Research Supporting the Potential of Zervimesine in Dry AMD (GlobeNewswire) - "Cognition Therapeutics, Inc...announced the publication of a manuscript reviewing recent work supporting the potential of zervimesine (CT1812), a small molecule drug candidate to treat dry age-related macular degeneration (dry AMD)...'We analyzed CSF samples from studies of zervimesine in adults with mild-to-moderate Alzheimer’s disease. From this, we found that treatment with zervimesine altered proteins and pathways strongly associated with geographic atrophy and macular degeneration. These findings support the potential of zervimesine to impact pathways impaired in retinal diseases.'" Cognition Therapeutics also worked with Arjuna Ratnayaka, Ph.D. in the School of Clinical and Experimental Sciences at the University of Southampton to conduct an in vitro study showing the potential that a small molecule candidate may rescue cellular processes that are impaired in dry AMD."

Preclinical • Age-related Macular Degeneration • Alzheimer's Disease

Cognition Therapeutics Successfully Passes Pre-defined Futility Analysis of Phase 2 Study of Oral Zervimesine (CT1812) in Geographic Atrophy (GlobeNewswire) - P2 | N=100 | MAGNIFY (NCT05893537) | Sponsor: Cognition Therapeutics | "Cognition Therapeutics, Inc...reported a positive outcome of an analysis of masked data from the ongoing ‘MAGNIFY’ Phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD)...Results of the futility analysis from the first 57 participants who completed at least 6 months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo...All participants are completing a final clinic visit in February 2025. Cognition intends to unblind the study at the end of February and provide a complete analysis of the study, including 12 months of dosing, in the second quarter of 2025."

P2 data • Trial status • Dry Age-related Macular Degeneration • Ophthalmology

Cognition Therapeutics’ VP of Research Co-hosting Precision Medicine Workshop at the Neuroimmunology Drug Development Summit (GlobeNewswire) - "Cognition Therapeutics...announced that Mary Hamby, PhD will be co-hosting a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit. The workshop will review methods of screening participants for clinical trials to ensure that the patients selected are most likely to benefit from treatment...Dr. Hamby will present an overview of the findings from Cognition’s Phase 2 ‘SHINE’ study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer’s disease....The Hanson Wade Neuroimmunology Drug Development Summit is taking place February 25-27, 2025 in Boston, MA."

P2 data • Alzheimer's Disease