Cyclerion Therapeutics and Beacon Biosignals Announce Expanded Strategic Partnership
July 08 2021 - 04:30PM
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 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. 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 InvestorsCarlo Tanzi, Ph.D.Kendall
Investor Relationsctanzi@kendallir.com
Cyclerion MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
Beacon Biosignals MediaJacob Donoghue M.D.,
Ph.D.jake@beacon.bio
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