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– In preclinical study, treatment with company’s investigational sGC stimulator olinciguat was associated with improved blood flow and reduced inflammation in a model of sickle cell disease –
– New research supports the need for a novel patient-reported outcome (PRO) instrument to measure sickle cell disease symptoms from the patient perspective –
CAMBRIDGE, Mass., June 04, 2019 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (CYCN), a clinical-stage biopharmaceutical company developing soluble guanylate cyclase (sGC) stimulators for the treatment of serious and orphan diseases, today announced upcoming data presentations supporting its therapeutic approach in sickle cell disease (SCD) during the 24th European Hematology Association (EHA) Congress, held June 13-16 in Amsterdam. The company will also present an overview of olinciguat, its sGC stimulator under clinical investigation in the Phase 2 STRONG SCD study as a potential treatment for sickle cell disease, at the 13th Annual Sickle Cell Disease Research and Educational Symposium, hosted by the Foundation for Sickle Cell Disease Research (FSCDR), and held June 7-9 in Fort Lauderdale, Florida.
“We continue to build a body of evidence to support the advancement of our sGC stimulator olinciguat, which we believe has the potential to be a life-changing medicine for patients with sickle cell disease,” said Chris Wright, M.D., Ph.D., Chief Medical Officer at Cyclerion. “We are looking forward to sharing our latest preclinical and clinical work at EHA and FSCDR and to furthering knowledge and innovation on behalf of these patients. We are committed to working with the sickle cell community to better understand patients’ daily challenges and to incorporate patient perspectives into our clinical program.”
Cyclerion is focused on unlocking the full therapeutic potential of the nitric oxide-cyclic guanosine monophosphate (cGMP) signaling pathway, a clinically validated pathway with potential for therapeutic applications in a wide range of cardiovascular, metabolic, inflammatory, fibrotic and neurological diseases. sGC is a key node in this pathway, and Cyclerion’s targeted sGC stimulators are designed to enhance pathway signaling in the tissues of greatest relevance to the diseases each is intended to treat. Olinciguat is Cyclerion’s investigational sGC stimulator designed to target the vasculature.
Cyclerion’s Upcoming SCD Presentations:
13th Annual Sickle Cell Disease Research and Educational Symposium – June 7-9, 2019, Fort Lauderdale Marriott Harbor Beach Resort & Spa
Cyclerion will present a brief overview of olinciguat, its investigational treatment for sickle cell disease, and an update on the ongoing Phase 2 STRONG SCD study during the Investigational New Drug, Therapeutic, and Device Symposium.
Presenter: Bina Tejura, Senior Medical Director, Cyclerion
Friday, June 7, 4:30-6:30 p.m. EDT
Location: Caribbean IV – V
Cyclerion will sponsor “Men Living Well with Sickle Cell,” a pre-FSCDR town hall, in collaboration with FSCDR, BlackDoctor.org, and Sickle Cell Association of Houston.
Thursday, June 6, 7:00 p.m. EDT
Location: Fort Lauderdale Antique Car Museum
24th European Hematology Association (EHA) Congress – June 13-16, 2019, RAI Amsterdam
Cyclerion will present the results of a series of sickle cell disease patient and clinician interviews and a literature review conducted to better understand the symptoms that patients consider to be most important and relevant to their daily experience, as well as an assessment of existing patient-reported outcome (PRO) tools to evaluate how well each tool measures these symptoms.
Presenter: Funke Ojo, Senior Manager, Study Endpoints, Cyclerion
Friday, June 14, 5:30-7:00 p.m. CEST
Location: Poster area
Cyclerion preclinical research will also be presented demonstrating that its investigational sGC stimulator olinciguat was associated with improved blood flow and reduced inflammatory response caused by interactions between leukocytes and endothelial cells in a sickle cell disease model.
Presenter: Huihui Li, Cell Biology Postdoctoral Fellow, Albert Einstein College of Medicine
Saturday, June 15, 5:30-7:00 p.m. CEST
Location: Poster area
Olinciguat is an investigational, orally administered, once-daily, vascular sGC stimulator designed for the treatment of sickle cell disease (SCD). SCD is an inherited red blood cell disorder that causes red blood cells to deform into a sickle shape, impacting blood flow to organs and tissues. These sickled red blood cells are more susceptible to hemolysis (rupturing). Upon red blood cell rupturing, nitric oxide is depleted due to arginase release and hemoglobin scavenging. Nitric oxide is an important regulator of blood flow, and the resulting deficiency of nitric oxide is believed to contribute to symptoms of SCD.
As sGC is a key node in the nitric oxide signaling pathway, olinciguat has the potential to address key symptoms and complications of SCD by addressing the disease’s underlying nitric oxide deficiency. The distribution of olinciguat to the vasculature as well as to organs with high blood flow, such as the kidney and lungs, may make it well suited for the potential treatment of SCD.
Olinciguat has been granted Orphan Drug Designation for SCD by the U.S. Food and Drug Administration and is currently in a Phase 2 study in patients with SCD, the STRONG SCD study.
About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of soluble guanylate cyclase (sGC) pharmacology to discover, develop and commercialize breakthrough treatments for serious and orphan diseases. Cyclerion is advancing its portfolio of five differentiated sGC stimulator programs with distinct pharmacologic and biodistribution properties that are uniquely designed to target tissues of greatest relevance to the diseases they are intended to treat. These programs include olinciguat in Phase 2 development for sickle cell disease, praliciguat in Phase 2 trials for heart failure with preserved ejection fraction (HFpEF) and for diabetic nephropathy, IW-6463 in Phase 1 development for serious and orphan central nervous system diseases, and two late-stage discovery programs targeting serious liver and lung diseases, respectively.
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. 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. 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 risk that we may be unable to make, on a timely or cost-effective basis, the changes necessary to operate as an independent company; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates; the risk of a delay in the enrollment of patients in our clinical studies; the risk that any one or more of our product candidates will not be successfully developed, approved or commercialized; our lack of independent operating history and the risk that our accounting and other management systems may not be prepared to meet the financial reporting and other requirements of operating as an independent public company; the risk that the separation from Ironwood may adversely impact our ability to attract or retain key personnel; and the other risks and uncertainties listed under the “Risk Factors” section and elsewhere in our Quarterly Report on Form 10-Q filed on May 13, 2019, with the Securities and Exchange Commission (SEC), and in subsequent reports that we file with the SEC. 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 we undertake no obligation to update these forward-looking statements, except as required by law.
Brian Cali, (857) 338-3262
Jessi Rennekamp, (857) 338-3319