Cyclerion Therapeutics Announces CY6463 Data Demonstrating Improved Cellular Energetics in Preclinical Models of Mitochondrial Disease
June 17 2022 - 8:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, today announced research from
preclinical studies demonstrating treatment with its lead soluble
guanylate cyclase (sGC) stimulator, CY6463, was associated with
improved cellular energetics and reduced inflammation in
preclinical models of mitochondrial disease. The data will be
presented today at the 10th International Conference on cGMP,
taking place June 17-19, 2022, in Augsburg, Germany.
“We’re excited to share results highlighting the beneficial
impact of sGC stimulation in multiple preclinical models of
mitochondrial disease,” said Juli Jones, Ph.D, Head of Disease
Biology at Cyclerion Therapeutics. “These results are consistent
with our recent clinical data in MELAS patients demonstrating that
CY6463 was associated with improvements across multiple domains of
disease activity, including mitochondrial function and
inflammation, and further support the therapeutic potential of
CY6463 to address a broad range of diseases characterized by
mitochondrial dysfunction.”
Data will be presented by Emmanuel Buys, Ph.D., Head of Network
Excellence at Cyclerion Therapeutics in a poster titled, “CY6463, a
CNS-penetrant sGC stimulator, elicits benefits in preclinical
models of mitochondrial complex 1 deficiency” during today’s poster
session. The poster is made available on the Cyclerion website on
the following link.
Presentation highlights:
- CY6463 significantly increased ATP
levels in lymphoblasts derived from patients with mitochondrial
complex 1 deficiency (Leber hereditary optic neuropathy or Leigh
syndrome)
- CY6463 restored mitochondrial gene
expression in lymphoblasts derived from patients with mitochondrial
complex 1 deficiency (Leber hereditary optic neuropathy or Leigh
syndrome)
- CY6463 significantly decreased the
astrocytic marker, GFAP, linked to inflammation in a mouse model of
mitochondrial complex 1 deficiency
About CY6463CY6463 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 Mitochondrial
Encephalomyopathy, Lactic Acidosis and Stroke-like episodes
(MELAS), Cognitive Impairment Associated with Schizophrenia (CIAS)
and Alzheimer's Disease with Vascular pathology (ADv). Cyclerion is
also advancing CY3018, a next-generation sGC stimulator.
Forward Looking
StatementCertain matters discussed in this press release
are “forward-looking statements”. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should”, “positive” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
success, timing and cost of our ongoing or future clinical trials
and anticipated clinical trials for our current product candidates;
our ability to fund additional clinical trials to continue the
advancement of our product candidates; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration
(“FDA”) or other regulatory authority approval of, or other action
with respect to, our product candidates; the Company’s ability to
successfully defend its intellectual property or obtain necessary
licenses at a cost acceptable to the Company, if at all; the
successful implementation of the Company’s research and development
programs and collaborations; the acceptance by the market of the
Company’s product candidates, if approved; and other factors,
including general economic conditions and regulatory developments,
not within the Company’s control. The factors discussed herein
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
The forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstance.
For more information about Cyclerion, please visit cyclerion.com
and follow us on Twitter and LinkedIn.
Investors
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
Media
Amanda Sellers
Verge Scientific Communications
asellers@vergescientific.com
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