Cyclerion Announces Phase 2 STRONG-SCD Study Results in Patients with Sickle Cell Disease
October 14 2020 - 7:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company, today announced top-line results from
its STRONG-SCD study of olinciguat, an investigational,
orally-administered, once daily, vascular sGC stimulator for the
potential treatment of sickle cell disease (SCD). Olinciguat was
generally well tolerated across all dose ranges. Results did not
demonstrate adequate activity to support further internal clinical
development. Cyclerion intends to complete its analysis of the
study results and present or publish them in a future forum.
“We would like to thank all of the sickle cell patients who
participated in the STRONG-SCD study, the SCD advocacy community,
and the investigators and study staff who focused their time and
efforts on helping us better understand the potential of olinciguat
in sickle cell disease,” said Peter Hecht, Ph.D., Chief
Executive Officer of Cyclerion. “While we are disappointed that we
won’t be contributing a much-needed new treatment option for SCD,
we are continuing to analyze the data to understand several
potential biomarker signals, including inflammation, as we explore
partnership options for this program.”
As described in the Company’s IW-6463 press release also issued
today, Cyclerion expects to be focused on the development of
treatments for serious diseases of the central nervous system
(CNS).
About STRONG-SCD StudyThe
STRONG-SCD study is a randomized, placebo-controlled, dose-ranging
Phase 2 study of 70 participants designed to evaluate safety,
tolerability, and pharmacokinetics of olinciguat, compared to
placebo, as well as to explore effects on daily symptoms and
biomarkers of disease activity when dosed over a 12-week treatment
period.
About Cyclerion TherapeuticsCyclerion
Therapeutics is a clinical-stage biopharmaceutical company focused
on discovering, developing and commercializing innovative medicines
for people with serious diseases of the central nervous system
(CNS). Cyclerion’s lead program is IW-6463, a pioneering
CNS-penetrant sGC stimulator in clinical development for
Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like
episodes (MELAS) and Alzheimer's Disease with Vascular pathology
(ADv).
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 results and conduct of our Phase 2
proof-of-concept clinical trial of olinciguat; our interpretation
of the data from the clinical trial; the potential further
evaluation of olinciguat; the potential strategic options for
olinciguat; the clinical potential of olinciguat; our future
business focus; advancing our other clinical trials; and the
business and operations of Cyclerion. 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. 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. Applicable
risks and uncertainties include the risks listed under the heading
“Risk Factors” and elsewhere in our 2019 Form 10-K filed on March
12, 2020, and in Cyclerion’s subsequent SEC filings, including the
Form 10-Q filed on May 4, 2020 and the Form 10-Q filed on August 3,
2020.
InvestorsCarlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallir.com
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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