Cyclerion Therapeutics Hosted Webinar to Discuss Pipeline Progress
April 27 2021 - 9:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, hosted a webinar today to provide
clinical updates for its first-in-class, CNS-penetrant soluble
guanylate cyclase (sGC) stimulator CY6463 in Alzheimer's Disease
with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy,
Lactic Acidosis and Stroke-like episodes (MELAS). Supported by
recent clinical and preclinical data, Cyclerion also discussed the
potential for CY6463 to treat Cognitive Impairment Associated with
Schizophrenia (CIAS), with key insights from Dr. Andreas Reif on
the role of the sGC pathway in the disease. In addition, Cyclerion
introduced its latest development candidate CY3018, a
differentiated, next-generation, CNS-penetrant sGC stimulator.
“To deliver on our mission to develop treatments that restore
cognitive function, we are harnessing the momentum and insights
from our preclinical and clinical data on the fundamental role of
the NO-sGC-cGMP pathway in central nervous system diseases,” said
Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion.
“Following the science, we see the potential to unlock significant
opportunities across a number of patient populations with cognitive
impairment, who are in desperate need of new therapeutic
options.”
Key Webinar Highlights
- Modulating a fundamental CNS signaling
pathway: sGC stimulators amplify the power of the nitric
oxide‐soluble guanylate cyclase‐cyclic guanosine monophosphate
pathway (NO-sGC-cGMP) signaling to address central aspects of
disease pathophysiology. Preclinical data from CY6463 and extensive
academic work validate the crucial role of the sGC pathway in brain
physiology. Clinical data from the recent translational
pharmacology study confirm the ability of CY6463 to impact brain
oscillations, neuroinflammation and neurophysiological
function.
- CY6463 Updates
- Disease-relevant, biomarker-guided pipeline
strategy: The company is advancing parallel,
signal-seeking, exploratory studies in well-defined patient
populations with cognitive impairment including neurodegenerative,
neuropsychiatric, and mitochondrial diseases. CY6463 targets sGC, a
proven druggable target, in critical brain regions and cell types
linked to cognition and has demonstrated an impact on multiple
biomarkers associated with cognition in previous Phase 1
studies.
- ADv clinical trial initiation: The U.S. Food
and Drug Administration (FDA) cleared the Investigational New Drug
(IND) application for CY6463 in ADv, and the Company anticipates
beginning to enroll patients in a 12-week Phase 2a clinical trial
in patients with ADv by mid-2021, barring any COVID-19 related
delays. This exploratory study is designed to evaluate safety,
tolerability, and pharmacodynamic effects including impact on
disease-relevant biomarkers.
- MELAS clinical trial advancement: This study
is enrolling more slowly than initially projected, primarily due to
COVID-19. Data from the exploratory 29-day open-label Phase 2a
pilot study in patients with MELAS are now expected by year end
2021.
-
Potential to treat CIAS with novel mechanism:
Neuropsychiatric key opinion leader and expert in the neurobiology
of nitric oxide and its relation to psychiatric disorders, Andreas
Reif, M.D., Chair, Department of Psychiatry, University Hospital
Frankfurt, discussed the sGC pathway and its role in cognitive
function and CIAS. Reduced NO-sGC-cGMP signaling is linked to
cognitive dysfunction in schizophrenia. Stimulation of sGC by
CY6463 to amplify NO-sGC-cGMP signaling is a potential
first-in-class approach for the treatment of CIAS. Cyclerion is
planning to initiate a Phase 1b signal-seeking study in CIAS to
evaluate safety and near-term impact on disease-relevant
biomarkers.
- CY3018, a differentiated,
next-generation CNS-penetrant sGC stimulator: Cyclerion
shared information on the latest development candidate, CY3018.
Preclinical data show increased CNS-exposure, with significantly
increased cerebrospinal fluid (CSF) to plasma ratio, compared to
CY6463. This increased CNS distribution is mirrored by a higher
level of pharmacological activity in the CNS relative to the
periphery. The company is advancing CY3018 through IND-enabling
development.
“We are using insights from our preclinical and clinical data to
tap into a fundamental CNS signaling pathway with CY6463 – our
first-in-class, CNS-penetrant sGC stimulator,” said Andy Busch,
Ph.D., Chief Scientific Officer at Cyclerion. “We are excited by
the data from our CY6463 translational pharmacology study that
demonstrated rapid improvement in biomarkers associated with
cognition and reflect CY6463’s multidimensional pharmacology. These
data are leading us to explore opportunities in cognition through
the sGC pathway.”
Cash, cash equivalents, and restricted cash balance on March 31,
2021 was approximately $45 million, as compared to approximately
$58 million on December 31, 2021. As of April 2021, Cyclerion has
substantially streamlined its operating model to invest more fully
in its priority opportunities in cognition and expects average
monthly cash use for the foreseeable future to be approximately 50
percent that of 2020.
Webinar Replay Information A
replay of the event can be accessed by visiting the investors'
section of the Cyclerion website
at 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)
and 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 StatementThis 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 discovery
programs into clinical development; 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 those related to the possibility that any
results of operations and financial condition of the Company
reported are preliminary and subject to final audit and 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. 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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