CGTX

Cognition Therapeutics, Inc. (Nasdaq: CGTX) today announced that the first patient has been dosed in its double-blind, placebo-controlled, randomized Phase 2 SHIMMER clinical trial of CT1812 in patients with dementia with Lewy bodies (DLB). CT1812 is an experimental, orally delivered small molecule therapeutic intended to address the underlying biology of DLB.

“Dementia with Lewy bodies is a devastating disease that has no disease-modifying treatments and impacts millions of people around the globe, yet remains under-funded and under-researched,” stated James E. Galvin, MD, MPH, the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and primary investigator in the Phase 2 study. “This Phase 2 study provides me and my colleagues at other sites in the Lewy Body Dementia Consortium an opportunity to investigate a unique mechanism of action that has the potential to impact the progression of DLB. I’m looking forward to working with the team at Cognition to assess this novel medication.”

DLB is a multi-faceted disorder characterized by the accumulation of α-synuclein fibrils, the major constituent of the Lewy bodies that occur inside brain neurons, which exert deleterious effects across brain structures. In addition, many patients with DLB also have a buildup of Aβ oligomers. Together, the accumulation of pathogenic proteins in DLB is believed to be due in part to a failure of autophagy and other key cellular functions. Further evidence suggests that these processes are regulated by the sigma-2 (σ-2) receptor, which is the biological target of CT1812. Cognition has previously published results supporting the use of σ-2 receptor modulators such as CT1812 to protect neurons from the toxic insults from α-synuclein and Aβ oligomers. It is anticipated that its mechanism of action may thus enable CT1812 to address the dual assault from α-synuclein and Aβ oligomers in patients with DLB.

Cognition anticipates enrolling 120 adults between 50 and 80 years of age with a DLB diagnosis, who will be randomized to receive placebo or one of two daily (QD) doses of CT1812 for six months. In addition to safety, this study will compare changes in cognitive performance, physical activity, and pharmacokinetic and pharmacodynamic biomarkers to baseline measurements. Furthermore, cerebrospinal fluid (CSF) will be collected and analyzed for α-synuclein content and established patterns of differential protein expression.

“DLB is a poorly understood disease with no approved treatments and few active clinical research efforts. We are excited to explore the potential that our σ-2 receptor modulator, CT1812, may have therapeutic benefit for patients with this intractable disease,” added Anthony O. Caggiano, M.D., Ph.D., chief medical officer and head of R&D at Cognition Therapeutics. “Initiation of patient treatment in this interventional study is an important milestone for Cognition Therapeutics and for the DLB community. We are grateful to our collaborators at the Lewy Body Dementia Association (LBDA) and the Miller School of Medicine; as well as the continued support from the National Institute on Aging, who awarded Cognition the largest grant to date to study DLB.”

The Phase 2 SHIMMER study (COG1201) is supported by a $30 million grant (R01AG071643) from the National Institutes of Health’s National Institute on Aging. More information including trial inclusion and exclusion criteria may be found under reference number NCT05225415 at www.clinicaltrials.gov.

About Dementia with Lewy BodiesAn estimated 1.4 million Americans are living with DLB, a progressive disease that accounts for approximately 5-10% of all dementia cases. DLB, has overlapping pathology and symptomology of Parkinson’s and Alzheimer’s diseases, making it challenging to diagnose. DLB is caused by a build-up of a protein, α-synuclein, which forms deposits, called Lewy bodies, in the brain. Oligomers of α-synuclein are highly toxic and bind to neurons where they impair critical cellular processes, causing synaptic dysfunction and loss. Patients with DLB often experience cognitive, physical, sleep and behavioral symptoms, including hallucinations, delusions and mood changes. There are currently no disease-modifying treatments approved for DLB patients.

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 diseases and 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.

Editor’s note: The content is solely the responsibility of Cognition Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

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Contact Information:Cognition Therapeutics, Inc.info@cogrx.com

Aline Sherwood (media)Scienta Communicationsasherwood@scientapr.com

Daniel Kontoh-Boateng (investors)Tiberend Strategic Advisors, Inc.dboateng@tiberend.com