Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) and Ariana Pharma today
announced an artificial intelligence-driven, precision medicine
collaboration. This collaboration is expected to identify
biomarkers of response to refine patient selection to guide and
accelerate the clinical development of Cyclerion’s investigational
therapeutics for neurological and neuropsychiatric diseases
associated with cognitive impairment.
Ariana Pharma’s proprietary KEM® (Knowledge
Extraction and Management) eXplainable Artificial Intelligence
(xAI) technology aims at significantly increasing success rates and
accelerating clinical development timelines by fully evaluating
complex clinical study data, including the discovery of hidden
pharmacological and efficacy signals that may be beyond the reach
of conventional statistical analyses. This approach enables
identification of specific target patient populations, as well as
biomarkers of therapeutic response for future clinical studies.
Ariana Pharma and Cyclerion will initially focus
on supporting the development of CY6463, Cyclerion’s lead clinical
program. The collaboration will analyze data from completed Phase 1
clinical studies of CY6463, including a completed translational
pharmacology study in healthy elderly subjects, as well as an
ongoing study in Cognitive Impairment Associated with Schizophrenia
(CIAS). Insights from these analyses are expected to accelerate and
support further clinical development of CY6463.
CY6463 is an oral, first-in-class, central
nervous system (CNS)-penetrant sGC stimulator that is being
developed for neurological and neuropsychiatric diseases associated
with cognitive impairment. CY6463 was designed to address multiple
pathophysiological features of these disorders. Results from
initial CY6463 clinical studies have demonstrated favorable safety
and tolerability and pharmacologically relevant drug exposure in
the cerebral spinal fluid. Furthermore, promising impacts on EEG
measures, neuroinflammation, and other measures support the current
clinical development of CY6463. In addition to the ongoing study in
CIAS, studies to evaluate CY6463 safety and signals of clinical
activity are also ongoing in participants with Alzheimer's Disease
with vascular pathology (ADv) and Mitochondrial Encephalomyopathy,
Lactic Acidosis and Stroke-like episodes (MELAS). Cyclerion expects
to obtain clinical results from the MELAS and CIAS studies in Q2
2022 and 2H 2022, respectively. The ADv study initiated patient
dosing in January 2022 and enrollment is ongoing.
“Ariana integrates disease biology, mechanism
information, and pre/clinical data in their AI platform. This
multidimensional machine learning approach, based on Formal Concept
Analysis, identifies all possible relationships, the strongest of
which may form the basis of drug-specific patient selection and/or
surrogate pharmacology/efficacy markers and identify additional
indications. We believe that Ariana’s extensive drug development
experience in the CNS and 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 collaboration
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 pioneering
eXplainable AI platform KEM® to support the development of
Cyclerion’s promising therapeutic candidates. We believe that our
platform has the capacity to help guide the selection of patients
who may benefit most from the therapy, by identifying
patient-selection biomarkers, and the right measure of therapeutic
efficacy, by identifying pharmacodynamic biomarkers, and optimal
endpoints for future clinical development. We are excited about the
prospect of using our xAI to accelerate the precision medicine
development of CY6463 towards effective treatments against
devastating neurological and neuropsychiatric diseases,” said
Mohammad Afshar, M.D., Ph.D., Chief Executive Officer of Ariana
Pharma.
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 Ariana PharmaAriana Pharma is a
leading Artificial Intelligence (AI) drug development company.
Using its KEM® Artificial Intelligence (xAI) technology, Ariana
helps its partners introduce personalized medicine clinical trial
design into their protocols and optimize clinical endpoints,
identify biomarkers of therapeutic response and potential
synergistic therapies. Ariana routinely collects and combines
clinical data with omic data, immunological readouts (such as
Fluorescence-Activated Cell Sorting (FACS)), microbiota, Patient
Reported Outcomes (PRO) as well as Real World Evidence (RWE) data.
Combining advanced data analytics, drug development, and regulatory
expertise, Ariana helps translate findings into innovative clinical
development plans and regulatory approvals. With a growing number
of successful therapeutic development programs, KEM® is an
FDA-assessed technology that systematically explores combinations
of biomarkers, producing more effective biomarker signatures for
precision medicine. Ariana has developed Onco KEM®, the most
advanced, clinically tested, oncology therapeutic decision support
system. Founded in 2003 as a spin-off of the Institut Pasteur,
Paris, France, the company operates a subsidiary in the United
States since 2012. Further information is available at
www.arianapharma.com.
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, 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.
Cyclerion InvestorsCarlo Tanzi, Ph.D.Kendall
Investor Relationsctanzi@kendallir.com
Cyclerion MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
Ariana Pharma MediaThomas
Turcatt.turcat@arianapharma.com
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