Cognition Therapeutics Announces Positive Results in Phase 2 Study of CT1812 in Dementia with Lewy Bodies

- Improvements Across Measures of Behavior, Function, Cognition and Movement -

- Expediting Plans to Advance CT1812 into Late-Stage Trials -

- Full Results to be Presented at International Lewy Body Dementia Conference (ILBDC) -

- Cognition Therapeutics and Dr. Galvin, a Principal Investigator, Will Host a Conference Call at 8am ET on December 18 to Review the Topline Data -

PURCHASE, N.Y., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced topline results from the exploratory Phase 2 ‘SHIMMER' study demonstrating CT1812 produced strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB).

"The results from this exploratory Phase 2 trial demonstrated CT1812 could have a meaningful, positive impact on DLB patients across multiple measures of cognitive, behavioral, movement, and functional performance. DLB is a multifactorial disease where patients experience a constellation of symptoms, and the results of this study suggest CT1812 holds promise for DLB patients and their care providers," stated James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and a principal investigator in the SHIMMER study. "I believe the SHIMMER topline results are both exciting and very promising, and I am looking forward to working with the team at Cognition as they determine the appropriate next steps for CT1812."

Designed as a signal-finding study, the SHIMMER Phase 2 study enrolled 130 patients with mild-to-moderate DLB who were randomized to receive one of two oral doses of CT1812 or placebo daily for six months. Results indicate the study met its primary endpoint of safety and tolerability, with data showing that DLB patients treated with CT1812 for six months experienced improvement in behavioral, functional, cognitive and movement measures compared to placebo. Importantly, there was an 82% slowing in the total neuropsychiatric inventory (NPI) with particularly strong reduction in anxiety, hallucinations, and delusions in the CT1812 treated arms. In addition, there was a marked reduction in caregiver distress, which suggests a positive impact on the day-to-day lives of those receiving the drug. Participants treated with CT1812 experienced a slowing of decline across all three cognitive measures compared to placebo, including fluctuations in attention which declined by 91%.   Detailed data will be presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025.

"These topline results exceeded our expectations and support the broad potential of CT1812 across neurodegenerative disorders," stated Anthony Caggiano, M.D., Ph.D., Cognition's chief medical officer and head of R&D. "Analysis of CT1812's activity in DLB will continue as additional data become available. We look forward to reporting these findings at future medical meetings and reviewing them with the FDA in an end-of-Phase 2 meeting."

"With the SHIMMER and SHINE results, we are confident in CT1812's clinical activity given that it has demonstrated broad neurologic and neuroprotective activity in DLB and Alzheimer's disease," stated Lisa Ricciardi, Cognition's president and CEO. "People with these diseases, particularly DLB, have few therapeutic options leading to a cascade of symptoms that are painful to the individual and their caregivers. We are eager to continue the development of CT1812 in late-stage clinical trials with the hope of providing a once-daily pill that can treat these devasting neurodegenerative conditions."

Investor Webinar Details:

Cognition will review these topline efficacy and safety findings on a webcast conference call at 8:00 a.m. ET today, December 18, 2024. This event will feature a discussion with James E. Galvin, M.D., M.P.H., founding director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and principal investigator in the SHIMMER study. A live question and answer session will follow formal presentations. The live and archived webcast may be accessed from the Investor Relations section of the Cognition website under News & Events or directly by visiting https://lifescievents.com/event/cogrx/.  

James E. Galvin, M.D., M.P.H. is professor of neurology and psychiatry & behavioral sciences, and the Alexandria and Bernard Schoninger Endowed Chair for Memory Disorders at the University of Miami Miller School of Medicine. He is division chief for cognitive neurology, founding director of the Comprehensive Center for Brain Health, and director and principal investigator of the Lewy Body Dementia Research Center of Excellence. Dr. Galvin has authored over 400 scientific publications (h-index=73) and has received over $120 Million in research funding from the National Institutes of Health and Private Foundations. 

About Dementia with Lewy Bodies (DLB)

Dementia with Lewy bodies is the second most common cause of dementia, affecting an estimated 1.4 million Americans. The disease is believed to be caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies, which are found within brain neurons. DLB is referred to as a "whole-body" disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems. Varied initial symptoms may include day-to-day fluctuations in alertness level, hallucinations, delusions, movement disorders and REM sleep disorder (acting out dreams while sleeping). Treatments are used off-label to address some of these symptoms but there are currently no disease-modifying therapies approved.

About the SHIMMER Study

The SHIMMER study (NCT05225415) is an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants are assessed throughout the study using the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; 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 is being 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). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence.

Please note, this content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health's National Institute on Aging.

About CT1812

CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex, which is involved in the regulation of key cellular processes. These processes are disrupted by toxic interaction with Aβ or α-synuclein oligomers, oxidative stress and other disease drivers. The ensuing damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and disease progression.

Participants are currently being recruited in the START study (NCT05531656) of CT1812 in adults with early Alzheimer's disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration.

About Cognition Therapeutics, Inc. 

Cognition 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 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 that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.

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, including but not limited to, statements regarding our product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, the timing of any regulatory submissions, and expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials 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 impact of the COVID-19 pandemic on our business, supply chain and labor force; 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 www.sec.gov. 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, Inc. [email protected]

Casey McDonald (media)  Tiberend Strategic Advisors, Inc. [email protected]

Mike Moyer (investors) LifeSci Advisors  [email protected]

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