BOSTON, July 8, 2021 /PRNewswire/ -- Cyclerion
Therapeutics, Inc. (Nasdaq: CYCN) and Beacon Biosignals today
announced an extended and expanded strategic partnership between
the two companies. This collaboration is expected to identify
disease-relevant biomarkers to refine patient selection and
endpoints to guide the clinical development of Cyclerion's
investigational therapeutics for neurological diseases associated
with cognitive impairment.
Beacon Biosignals' EEG neurobiomarker platform is engineered to
discover and scale new clinical paradigms for patients with
neurological and psychiatric disease. Beacon Biosignals brings a
world-class clinical electroencephalogram (EEG) database coupled
with proprietary, artificial intelligence-based algorithms and
analytical capabilities to identify neurological biomarkers of drug
action and efficacy. Distinct EEG profiles are associated with
neurodevelopmental status and various neurological diseases, and
can be affected by neurologically active therapeutics. The platform
rapidly characterizes these effects and guides dose selection in
humans to help overcome the challenges of translating PK/PD models
from preclinical animal studies.
Beacon Biosignals and Cyclerion previously collaborated on the
analysis of data from a Cyclerion clinical translational
pharmacology study of CY6463 which demonstrated clear effects on
EEG parameters associated with aging and disease. These data were
recently presented at the annual meeting of the American Academy of
Neurology (Glasser et al., 2021). Incorporation of the Beacon
Biosignals approach in ongoing and planned Cyclerion patient
studies is expected to support the continued clinical development
of CY6463, the Company's lead clinical program, as well as CY3018,
a next-generation preclinical program.
CY6463 is an oral, first-in-class, central nervous system
(CNS)-penetrant sGC stimulator that is being developed for
neurological diseases associated with cognitive impairment. CY6463
was designed to address multiple pathophysiological features of
neurodegenerative and neuropsychiatric diseases associated with
cognitive impairment. Results from initial CY6463 clinical studies
have demonstrated favorable safety and tolerability and
pharmacologically relevant drug exposure in the cerebral spinal
fluid. In addition, CY6463 resulted in promising impacts on EEG
measures, neuroinflammation, and other neurophysiological measures
that support continued clinical development.
Patient studies to further evaluate CY6463 safety and signals of
clinical activity in studies in Alzheimer's disease with vascular
pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic
Acidosis and Stroke-like episodes (MELAS) are ongoing, and a study
in individuals with Cognitive Impairment Associated with
Schizophrenia (CIAS) is expected to initiate shortly. Analysis of
EEG and other neurological biomarkers will be an important aspect
of these studies.
"Beacon Biosignals is the leader in the identification of
disease-relevant EEG neurological biomarkers. We believe that the
application of this technology to our innovative pipeline may be
quite powerful in guiding efficient drug development, and we look
forward to a productive partnership focused on successfully
advancing CY6463 for diseases associated with cognitive
impairment," said Andy Busch Ph.D., Chief Scientific Officer of
Cyclerion Therapeutics.
"We are eager to apply our proprietary AI-based analytical
capabilities to support the development of Cyclerion's promising
therapeutic candidates. We believe that our platform has the
capacity to identify novel disease-relevant biomarkers that may
help guide patient selection or endpoint identification for future
clinical development," said Jacob
Donoghue, M.D., Ph.D., Chief Executive Officer of Beacon
Biosignals.
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).
About Beacon Biosignals
Beacon's machine learning platform for EEG enables and accelerates
new treatments that transform the lives of patients with
neurological and psychiatric disease. Through novel machine
learning algorithms, enormous datasets, and advances in software
engineering, Beacon Biosignals is changing the way patients are
treated for disorders of the brain.
For more information about Beacon Biosignals, please visit
https://beacon.bio/ and follow us on Twitter (@biosignals) and
LinkedIn (https://www.linkedin.com/company/beacon-biosignals).
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. 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 Cyclerion's 2020 Form 10-K filed
on February 25, 2021, and 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.
Cyclerion Investors
Carlo
Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
Cyclerion Media
Amanda
Sellers
Verge Scientific Communications
asellers@vergescientific.com
Beacon Biosignals Media
Jacob
Donoghue M.D., Ph.D.
jake@beacon.bio
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SOURCE Beacon Biosignals