SV2A

Aug. 18, 2022 12:00 UTC NEEDHAM, Mass.--(BUSINESS WIRE)-- Invicro LLC (Invicro), a global, industry-leading imaging CRO, and a subsidiary of REALM IDx, Inc., today announced the publication of the paper “Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer’s disease1” in Science Translational Medicine. This press release features multimedia. View the full release here: Figure 1: Mean PET images demonstrating AD patients have widespread increases in sigma 1 receptor, along with regional decreases in mitochondrial complex I and SV2A. (Graphic: Business Wire) The study provides novel in vivo evidence for widespread, clinically relevant cellular stress and bioenergetic abnormalities in patients with early-stage Alzheimer’s Disease (AD) and highlights the potential value of mitochondrial imaging in longitudinal studies of AD. “Invicro’s research and novel biomarkers are significant for the progression of clinical trials in AD and neurodegenerative disorders, and we are delighted to see this important work published in Science Translational Medicine,” said Dr. Roger Gunn, CSO, Neuroscience, for Invicro. “This work further extends Invicro’s repertoire of biomarkers for use in AD clinical trials.” Position emission tomography and magnetic resonance imaging markers were utilized to show that cell stress and impaired oxidative phosphorylation are central to mechanisms of synaptic loss and neurodegeneration in the cellular pathology of AD. Compared to controls, AD patients had widespread increases in sigma 1 receptor, along with regional decreases in mitochondrial complex I, SV2A, brain volume and cerebral blood flow. Furthermore, significant reductions in mitochondrial density were seen in AD patients over a 12–18-month period, indicating this biomarker may be suitable for use in early-stage trials of novel disease-modifying treatment for this devastating disease. This study was led by Professor Paul Matthews of the UK Dementia Research Institute and Imperial College London as part of the multi-arm, pre-competitive consortium, Molecular Imaging of Neurodegenerative Disease — Mitochondria Associated Proteins and Synapses (MIND MAPS) AD cohort. The MIND MAPS consortium was developed and is headed by Dr. Eugenii Rabiner, EVP for Translational Imaging at Invicro. “MIND MAPS is an important industry-academic collaboration that is bringing together experts from across the globe. It was developed with the aim of characterizing imaging biomarkers of the neurodegenerative process to address important problems in the development of novel medication for neurodegenerative disease,” said Dr. Rabiner. “Together, we have shown that mitochondrial and cellular stress biomarkers open the promise of better monitoring of the therapeutic potential of these drugs.” Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational and clinical researchers from all established and emerging disciplines relevant to medicine. Science Translational Medicine published “Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer’s disease” on August 17, 2022. “Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer’s disease” Authors: Ashwin V Venkataraman, Ayla Mansur, Gaia Rizzo, Courtney Bishop, Yvonne Lewis, Ece Kocagoncu, Anne Lingford-Hughes, Mickael Huiban, Jan Passchier, James B. Rowe, Hideo Tsukada, David J. Brooks, Laurent Martarello, Robert A. Comley, Laigao Chen, Adam J. Schwarz, Richard Hargreaves, Roger N. Gunn, Eugenii A. Rabiner, and Paul M. Matthews About Invicro Headquartered in Needham, MA, Invicro, a subsidiary of REALM IDx, was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (preclinical through Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ. Invicro operates out of nine global laboratories, clinics and sites within the United States in Massachusetts, Michigan, California, Connecticut and globally in the United Kingdom, India, Japan and China. For more information visit

NEW YORK, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that Mary Hamby, Ph.D., vice president of research, presented results at the at Alzheimer’s Association International Conference (AAIC) of proteomic analysis of clinical biomarker data from the SPARC study of oral once-daily treatment with CT1812 in mild-to-moderate Alzheimer’s disease. The analytic results support the proposed synaptoprotective mechanism of action of CT1812 and role in normalizing cellular processes known to be adversely disrupted in Alzheimer's disease. The analyses demonstrated the effect of CT1812 on multiple priority Alzheimer’s biomarkers, including YKL-40, a biomarker of inflammation, which is upregulated in Alzheimer’s disease and is subject of intense focus by the field. Participants treated with CT1812 exhibited a downward shift in YKL-40 towards levels observed in healthy, non-demented individuals, supporting a positive impact of CT1812 on disease biology. “Increased levels of YKL-40 are a well-known indicator of inflammation. Given that patients treated with CT1812 demonstrated a decrease in this biomarker, we believe additional study is warranted to determine if this shift in YKL-40 signals a dampening of inflammation in the brain,” explained Dr. Hamby. “Also of note, CT1812 had a significant impact on CSF levels of clusterin (CLU), which has been identified as a genetic risk factor for Alzheimer’s disease by several independent, large-scale genome-wide association studies (GWAS).” “The data from this study build upon the biomarker analyses from the first cohort of the ongoing Phase 2 SHINE study,” added Lisa Ricciardi, Cognition’s president and CEO. “We are encouraged by the results thus far and we look forward to seeing how these findings translate into clinical benefit in Alzheimer’s patients, as the complete study reads out.” Dr. Hamby’s oral presentation: “CSF proteomics analysis to investigate the pharmacodynamic response of the S2R modulator CT1812 in Alzheimer’s disease patients from the SPARC clinical trial,” was held on August 4 in the virtual session: Biomarkers (non-neuroimaging) - Proteomics in Alzheimer’s disease and dementia with Lewy bodies (VO-5-12). The archived session is available on the AAIC platform through September 4, 2022. Dr. Hamby concluded, “We would like to thank our SPARC study collaborators at Yale Alzheimer's Disease Research Center, Emory University Integrated Proteomics Core and the University of Gothenburg for their collaborative efforts conducting the analyses we presented at AAIC and their insights interpreting the data.” About CT1812 CT1812 is an oral small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 (σ-2) receptor complex. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression. To date, CT1812 has been well tolerated in clinical studies to date. Mild and transient elevations of liver enzymes without indication of liver injury have been recorded. No SAEs have been reported in patients treated ​with CT1812.​ CT1812 is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. It is currently in development for mild-to-moderate Alzheimer’s disease in the SHINE study (NCT03507790 / shineADstudy.com) and dementia with Lewy bodies in the SHIMMER study (NCT05225415). About the SPARC Study In the SPARC study (NCT03493282), 23 participants were randomized to receive CT1812 or placebo for 24 weeks and were then assessed for safety, tolerability and impact on biomarkers of target engagement and disease progression. No significant treatment differences in synaptic density were observed in participants administered CT1812 or placebo, as measured by SV2a signal change compared to baseline. However, volumetric MRI showed a trend (p=0.0641) towards a reduction in the loss of composite brain volume in CT1812-treated patients (pooled) compared to placebo. In addition, in regions of the brain associated with learning and memory, the hippocampus, prefrontal and pericentral cortex, there was a nominally statistically significant reduction in brain volume atrophy. Among the 23 study participants, CT1812 was found to be generally well tolerated, consistent with findings from prior studies. Treatment-emergent adverse events (TEAEs) were well balanced across all treatment groups. Elevated liver enzymes occurred in three individuals in the treatment arm but resolved upon discontinuation of study drug. No serious TEAEs were recorded. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com/.

NEW YORK, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that Mary Hamby, Ph.D., vice president of research, presented results at the at Alzheimer’s Association International Conference (AAIC) of proteomic analysis of clinical biomarker data from the SPARC study of oral once-daily treatment with CT1812 in mild-to-moderate Alzheimer’s disease. The analytic results support the proposed synaptoprotective mechanism of action of CT1812 and role in normalizing cellular processes known to be adversely disrupted in Alzheimer's disease. The analyses demonstrated the effect of CT1812 on multiple priority Alzheimer’s biomarkers, including YKL-40, a biomarker of inflammation, which is upregulated in Alzheimer’s disease and is subject of intense focus by the field. Participants treated with CT1812 exhibited a downward shift in YKL-40 towards levels observed in healthy, non-demented individuals, supporting a positive impact of CT1812 on disease biology. “Increased levels of YKL-40 are a well-known indicator of inflammation. Given that patients treated with CT1812 demonstrated a decrease in this biomarker, we believe additional study is warranted to determine if this shift in YKL-40 signals a dampening of inflammation in the brain,” explained Dr. Hamby. “Also of note, CT1812 had a significant impact on CSF levels of clusterin (CLU), which has been identified as a genetic risk factor for Alzheimer’s disease by several independent, large-scale genome-wide association studies (GWAS).” “The data from this study build upon the biomarker analyses from the first cohort of the ongoing Phase 2 SHINE study,” added Lisa Ricciardi, Cognition’s president and CEO. “We are encouraged by the results thus far and we look forward to seeing how these findings translate into clinical benefit in Alzheimer’s patients, as the complete study reads out.” Dr. Hamby’s oral presentation: “CSF proteomics analysis to investigate the pharmacodynamic response of the S2R modulator CT1812 in Alzheimer’s disease patients from the SPARC clinical trial,” was held on August 4 in the virtual session: Biomarkers (non-neuroimaging) - Proteomics in Alzheimer’s disease and dementia with Lewy bodies (VO-5-12). The archived session is available on the AAIC platform through September 4, 2022. Dr. Hamby concluded, “We would like to thank our SPARC study collaborators at Yale Alzheimer's Disease Research Center, Emory University Integrated Proteomics Core and the University of Gothenburg for their collaborative efforts conducting the analyses we presented at AAIC and their insights interpreting the data.” About CT1812 CT1812 is an oral small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 (σ-2) receptor complex. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression. To date, CT1812 has been well tolerated in clinical studies to date. Mild and transient elevations of liver enzymes without indication of liver injury have been recorded. No SAEs have been reported in patients treated ​with CT1812.​ CT1812 is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. It is currently in development for mild-to-moderate Alzheimer’s disease in the SHINE study (NCT03507790 / shineADstudy.com) and dementia with Lewy bodies in the SHIMMER study (NCT05225415). About the SPARC Study In the SPARC study (NCT03493282), 23 participants were randomized to receive CT1812 or placebo for 24 weeks and were then assessed for safety, tolerability and impact on biomarkers of target engagement and disease progression. No significant treatment differences in synaptic density were observed in participants administered CT1812 or placebo, as measured by SV2a signal change compared to baseline. However, volumetric MRI showed a trend (p=0.0641) towards a reduction in the loss of composite brain volume in CT1812-treated patients (pooled) compared to placebo. In addition, in regions of the brain associated with learning and memory, the hippocampus, prefrontal and pericentral cortex, there was a nominally statistically significant reduction in brain volume atrophy. Among the 23 study participants, CT1812 was found to be generally well tolerated, consistent with findings from prior studies. Treatment-emergent adverse events (TEAEs) were well balanced across all treatment groups. Elevated liver enzymes occurred in three individuals in the treatment arm but resolved upon discontinuation of study drug. No serious TEAEs were recorded. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at . Forward Looking Statements This 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, other than statements of historical facts or statements that relate to present facts or current conditions, are forward-looking statements. These statements 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. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and are available at 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, Inc. info@cogrx.com Aline Sherwood (media) Scienta Communications asherwood@scientapr.com Daniel Kontoh-Boateng / Rosalyn Christian (investors) Tiberend Strategic Advisors, Inc. dboateng@tiberend.com / rchristian@tiberend.com