Cyclerion Announces Publication of Preclinical Data Demonstrating Reduction in Neuroinflammation by Brain-Penetrant sGC Stimulator
September 22 2021 - 8:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company developing treatments that restore
cognitive function, today announced a publication demonstrating
that administration of a small molecule soluble guanylate cyclase
(sGC) stimulator reduced markers associated with neuroinflammation
in multiple preclinical models. Neuroinflammation is a hallmark of
numerous CNS diseases, including Alzheimer’s disease and other
neurodegenerative diseases, and targeting this pathology is a
promising drug development strategy.
In preclinical research published in the Journal
of Neuroinflammation, a small molecule sGC stimulator was shown to
cross the blood-brain barrier and resulted in the stimulation of
cGMP levels in cerebral spinal fluid, providing evidence of
activation of the nitric oxide – sGC – cGMP pathway. Furthermore,
pharmacological sGC stimulation resulted in a statistically
significant decrease in the expression of several inflammatory
genes, including TNF, CD40, Icam1, Cybb, and GFAP, in rodent
models. These data suggest that CNS penetrant sGC stimulators, such
as Cyclerion development candidates CY6463 and CY3018, could
provide therapeutic benefit to individuals living with CNS diseases
associated with neuroinflammation.
“This research extends our understanding of the
pharmacology of brain-penetrant sGC stimulation and provides
further support for the potential of our investigational
therapeutics to treat CNS diseases. These new preclinical data
demonstrate that our approach is able to reduce neuroinflammation,
which is widely considered to be a core contributor of many serious
CNS diseases, including Alzheimer’s disease,” said Chris
Winrow, Ph.D. Study Author and Head of Translational Medicine,
Cyclerion Therapeutics. “A body of preclinical and clinical data
supports the development of CY6463 and CY3018, our brain-penetrant
sGC stimulators, and administration of CY6463 has been shown to
result in positive clinical
effects on multiple measures of brain
neurophysiology. We are eager to advance our ongoing CY6463
clinical studies to meaningful data readouts to more fully
understand the potential to provide individuals living with CNS
diseases with a meaningful clinical benefit.”
About CY6463CY6463 is the first
brain-penetrant sGC stimulator to be developed as a symptomatic and
potentially disease-modifying therapy for serious CNS diseases. The
nitric oxide (NO) – soluble guanylate cyclase (sGC) – cyclic
guanosine monophosphate (cGMP) signaling pathway is a fundamental
mechanism that precisely controls key aspects of physiology
throughout the body. In the CNS, the NO-sGC-cGMP pathway regulates
diverse and critical biological functions including neuronal
function, neuroinflammation, cellular bioenergetics, and vascular
dynamics. Although it has been successfully targeted with several
drugs in the periphery, this mechanism has yet to be fully
leveraged therapeutically in the CNS, where impaired NO-sGC-cGMP
signaling is believed to play an important role in the pathogenesis
of many neurodegenerative and neuropsychiatric diseases and other
disorders associated with cognitive impairment. As an sGC
stimulator, CY6463 acts as a positive allosteric modulator to
sensitize the sGC enzyme to NO, increase the production of cGMP,
and thereby amplify endogenous NO signaling. By compensating for
deficient NO-sGC-cGMP signaling, CY6463 and other sGC stimulators
may have broad therapeutic potential as a treatment to improve
cognition and function in people with for the treatment of serious
CNS diseases.
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-Qs filed
on April 30, 2021 and July 29, 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.
InvestorsCarlo Tanzi,
Ph.D.Kendall Investor Relationsctanzi@kendallir.com
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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