Cyclerion Therapeutics Announces Initiation of Patient Dosing in CY6463 Phase 2a Study in Alzheimer’s Disease with Vascular Pathology
January 26 2022 - 7:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, today announced that patient dosing has
begun in its Phase 2a study in Alzheimer’s Disease with Vascular
Pathology (ADv).
“The need for effective new treatments for Alzheimer’s disease
is immense, and, given the aging population demographics and
increasing rate of diagnosis, this need will continue to expand. We
believe that CY6463 has potential to provide meaningful cognitive
benefits and are very pleased to have initiated this important
clinical study,” said Andreas Busch, Ph.D., Chief Scientific
Officer of Cyclerion. “Our CY6463 ADv development efforts are
supported by preclinical data which demonstrate beneficial effects
on cognition measures and the neuronal and microglia cellular
activity thought to have a central role in the pathology and the
cognitive dysfunction experienced by individuals living with ADv.
Furthermore, a Phase 1 study in elderly subjects demonstrated an
impact on biomarkers relevant to neurodegeneration and cognitive
impairment. The ongoing Phase 2a study will focus on a segment of
the Alzheimer’s disease population where we believe our therapeutic
candidate has the best opportunity to provide a clinical benefit.
We expect this trial to deliver a rich dataset that will deepen our
understanding of the therapeutic potential of CY6463 and will
enable well-informed decisions regarding further development.”
The Phase 2a ADv study (NCT04798989) is a randomized,
placebo-controlled study of oral once-daily CY6463 in approximately
30 participants over a twelve-week dosing period. Study
participants must have confirmed Alzheimer’s disease pathology as
assessed by PET or CSF biomarkers, cardiovascular risk factors, as
well as mild-to-moderate subcortical small-vessel disease as
assessed by MRI. The study will evaluate safety, tolerability, and
pharmacokinetics as well as explore the impact on various
disease-relevant pharmacodynamic biomarkers (e.g., EEG, MRI,
neuroinflammatory biomarkers) and cognitive performance.
About CY6463
CY6463 is the first CNS-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 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, including statements about the anticipated timing of
release of topline results of our clinical trials; the progression
of our clinical programs; and the business and operations of the
Company. 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, July 29, 2021, and November 9, 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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