Cyclerion Therapeutics to Present Clinical Trial Design for CY6463 Phase 2a Study in Participants with Alzheimer’s Disease with Vascular Pathology at the Alzheimer’s Association International Conference 2021 (AAIC)

Rhea-AI Summary

Cyclerion Therapeutics (Nasdaq: CYCN) is set to present its Phase 2a study design for its lead candidate, CY6463, targeting Alzheimer’s disease with vascular pathology at the Alzheimer’s Association International Conference 2021, occurring from July 26-30, 2021. The research showcases neuropsychological biomarkers as predictors of cognitive performance in Alzheimer's patients. Cyclerion's innovative approach aims to restore cognitive function, as the company continues to advance treatments for various CNS disorders, with CY6463 demonstrating promise in earlier studies.

Positive

• Phase 2a study design for CY6463 presented, indicating progress in clinical development.
• Research highlights neuropsychological biomarkers that could enhance therapeutic outcomes.
• CY6463 has demonstrated rapid improvement in cognitive function biomarkers.

Negative

• None.

Research to be presented highlighting potential of neuropsychological biomarkers to guide the clinical development of Cyclerion’s investigational therapeutics

CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced that it will present clinical trial design for a Phase 2a study of its lead development candidate, CY6463, in participants with Alzheimer’s disease with vascular pathology at the upcoming Alzheimer’s Association International Conference 2021 (AAIC). AAIC will be held July 26-30, 2021, virtually and in Denver, CO.

In addition, Anna Marin, a researcher in the laboratory of Dr. Andrew Budson and Dr. Katherine Turk in the Department of Neurology, Boston University School of Medicine and Center for Translational and Cognitive Neuroscience, VA Boston Healthcare System, will present results from the Cyclerion sponsored study on peak alpha frequency and N200 latency as predictors of neuropsychological performance in a memory disorders clinic. This pioneering work provides insights into the relationships between electrophysiological measures and cognitive performance in patients with Alzheimer’s disease and other dementias. Cyclerion identified changes in electrophysiological measures in the recent Phase 1 Translational Pharmacology study and will be evaluating electrophysiological and cognitive endpoints in the Phase 2a study in participants with Alzheimer’s disease with vascular pathology.

Cyclerion Poster Presentation Details:

Title: Clinical trial design for a Phase 2a study evaluating the safety, tolerability, pharmacokinetics, and CNS activity of CY6463 in participants with Alzheimer’s disease with vascular pathology

Poster Number: P-54463

Presenter: Chad Glasser, Ph.D., Director of Clinical Research, Cyclerion Therapeutics

Authors: Chad Glasser, Jennifer Chickering, Phebe Wilson, Emily Florine, Chris Winrow, Chris Wright

The poster presentation will be available beginning at 8 a.m. MT / 10 a.m. ET Monday, July 26, on the AAIC meeting platform. The poster will also be available on the News & Events page of the Cyclerion website https://ir.cyclerion.com/news-events/event-calendar.

Center for Translational and Cognitive Neuroscience Poster Presentation Details:

Title: Peak alpha frequency and N200 latency as predictors of neuropsychological performance in a memory disorders clinic

Poster Number: P-54365

Presenter: Anna Marin B.A., Department of Neurology, Boston University School of Medicine; Center for Translational and Cognitive Neuroscience, VA Boston Healthcare System

Authors: Anna Marin B.A.^1,2, Kylie Schiloski B.A.², Naheer Lahdo B.A.², Ana Vives Rodriguez M.D.², Renee DeCaro Ph.D.², Andrew E. Budson M.D.^1,2, Katherine W. Turk M.D.^1,2

¹ Department of Neurology, Boston University School of Medicine; ²Center for Translational and Cognitive Neuroscience, VA Boston Healthcare System

The poster presentations will be available beginning at 8 a.m. MT / 10 a.m. ET Monday, July 26, on the AAIC meeting platform. The posters will also be available on the News & Events page of the Cyclerion website https://ir.cyclerion.com/news-events/event-calendar.

About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion is advancing novel, first-in-class, CNS-penetrant, sGC stimulators that modulate a key node in a fundamental CNS signaling pathway. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. The most advanced compound, CY6463, has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS), and Cognitive Impairment Associated with Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a next-generation sGC stimulator.

For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).

Forward Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021, and our subsequent SEC filings including the Form 10-Q filed on April 30, 2021. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law.

Investors
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com

Media
Amanda Sellers
Verge Scientific Communications
asellers@vergescientific.com

FAQ

What is the purpose of Cyclerion's Phase 2a study for CY6463?

The Phase 2a study aims to evaluate the safety, tolerability, and CNS activity of CY6463 in Alzheimer's disease patients with vascular pathology.

When will Cyclerion present its clinical trial design?

Cyclerion will present its clinical trial design at the Alzheimer's Association International Conference 2021 from July 26-30, 2021.

What are neuropsychological biomarkers in relation to CY6463?

Neuropsychological biomarkers refer to electrophysiological measures that predict cognitive performance in Alzheimer’s patients, which Cyclerion aims to utilize in its studies.

What are the implications of the results from Cyclerion's studies?

The results could provide insights into the effectiveness of CY6463 in improving cognitive function and guide future clinical development.

What type of diseases is CY6463 being developed to treat?

CY6463 is being developed to treat Alzheimer's disease with vascular pathology, as well as other CNS disorders.