Guanylate cyclase

Cyclerion Announces Mitochondrial Disease-Focused Corporate Strategy

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Thursday, October 6, 2022
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CAMBRIDGE, Mass., Oct. 06, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced its mitochondrial disease-focused corporate strategic plan. Propelled by the positive data from the recently completed CY6463 Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) clinical study, the Company believes it has a unique opportunity to deliver the first-ever approved medicine for patients suffering from rare mitochondrial diseases, a family of debilitating, progressive, and ultimately fatal genetic diseases.

Key Points: 
  • Recent positive MELAS clinical study data drive urgency to deliver potential first-ever therapy for patients with rare, genetic mitochondrial diseases
    CAMBRIDGE, Mass., Oct. 06, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced its mitochondrial disease-focused corporate strategic plan.
  • Organization: The Companys workforce is being tailored to the mitochondrial disease-focused strategy, leading to a reduction of approximately 45%, to 16 full-time employees.
  • Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments for mitochondrial diseases, including MELAS.
  • For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter ( @Cyclerion ) and LinkedIn ( www.linkedin.com/company/cyclerion ).

Cyclerion Announces CY6463 Clinical Pipeline Progress and Second Quarter 2022 Financial Results

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Tuesday, August 9, 2022
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CAMBRIDGE, Mass., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced second quarter 2022 financial results and a business update.

Key Points: 
  • Dr. Hecht continued: The promising clinical results we have seen to date strongly support the advancement of CY6463, a first-in-class, CNS-penetrant sGC stimulator.
  • Research & Development Expenses: R&D expenses were approximately $10.2 million for the second quarter of 2022, as compared to approximately $12.1 million for the second quarter of 2021.
  • General and Administrative Expenses: G&A expenses were approximately $3.5 million for the second quarter of 2022, as compared to approximately $6.2 million for the second quarter of 2021.
  • Net Loss: Net loss was approximately $13.4 million for the second quarter of 2022, as compared to $16.2 million for the second quarter of 2021.

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)

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Thursday, July 28, 2022
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CAMBRIDGE, Mass., July 28, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced positive topline data from its clinical study of CY6463 for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS) in individuals with stable schizophrenia on a stable, single, atypical antipsychotic regimen. Data from the 14-day, double-blind, randomized, placebo-controlled, multiple-ascending-dose study demonstrate that once-daily CY6463 was safe and well tolerated, with no reports of serious adverse events (SAEs), severe adverse events (AEs), or treatment discontinuation due to AEs. Study data demonstrate a strong effect on cognitive performance after two weeks of 15mg once-daily dosing. A broad positive movement on inflammatory biomarkers was also observed. These signals on exploratory endpoints provide further evidence of the pro-cognitive and anti-inflammatory effects of CY6463 observed in preclinical studies and prior clinical trials.

Key Points: 
  • I am encouraged by the promising cognition signals observed after only two weeks of CY6463 dosing in patients with stable schizophrenia.
  • These data demonstrate the therapeutic potential of amplifying sGC signaling in the CNS, including positive effects on cognition and inflammation, and support further development of CY6463 in diseases characterized by cognitive impairment.
  • The clinical study enrolled 48 participants with stable schizophrenia with no more than moderate positive symptoms and on a stable, single, atypical antipsychotic regimen.
  • Cognitive impairment is a core, debilitating, and untreated symptom of schizophrenia, with nearly all patients suffering from some cognitive deficits.

Cyclerion Therapeutics to Discuss CY6463 MELAS Clinical Data at a Webinar Hosted by United Mitochondrial Disease Foundation

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Wednesday, June 22, 2022
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CAMBRIDGE, Mass., June 22, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, will participate in a webinar hosted by the United Mitochondrial Disease Foundation (UMDF) on Tuesday, June 28th at 8 a.m. EDT with a live Q&A. The Company will provide an update on positive topline clinical data from the Phase 2a study of CY6463, a first-in-class CNS-penetrant sGC stimulator, in patients with Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about the webinar, please visit the resources page of the UMDF website.

Key Points: 
  • The Company will provide an update on positive topline clinical data from the Phase 2a study of CY6463, a first-in-class CNS-penetrant sGC stimulator, in patients with Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS).
  • We are encouraged by these early CY6463 study data and look forward to discussing study findings and their potential impact for people living with MELAS.
  • These highly encouraging data provide additional support for the therapeutic potential of CY6463 in MELAS, said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion.
  • The Phase 2a study was an open-label, single-arm study of oral, once-daily CY6463 in eight adults with MELAS.

Cyclerion Therapeutics Announces CY6463 Data Demonstrating Improved Cellular Energetics in Preclinical Models of Mitochondrial Disease

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Friday, June 17, 2022
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CAMBRIDGE, Mass., June 17, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced research from preclinical studies demonstrating treatment with its lead soluble guanylate cyclase (sGC) stimulator, CY6463, was associated with improved cellular energetics and reduced inflammation in preclinical models of mitochondrial disease. The data will be presented today at the 10th International Conference on cGMP, taking place June 17-19, 2022, in Augsburg, Germany.

Key Points: 
  • CAMBRIDGE, Mass., June 17, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced research from preclinical studies demonstrating treatment with its lead soluble guanylate cyclase (sGC) stimulator, CY6463, was associated with improved cellular energetics and reduced inflammation in preclinical models of mitochondrial disease.
  • The data will be presented today at the 10th International Conference on cGMP, taking place June 17-19, 2022, in Augsburg, Germany.
  • Were excited to share results highlighting the beneficial impact of sGC stimulation in multiple preclinical models of mitochondrial disease, said Juli Jones, Ph.D, Head of Disease Biology at Cyclerion Therapeutics.
  • Data will be presented by Emmanuel Buys, Ph.D., Head of Network Excellence at Cyclerion Therapeutics in a poster titled, CY6463, a CNS-penetrant sGC stimulator, elicits benefits in preclinical models of mitochondrial complex 1 deficiency during todays poster session.

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in MELAS Patients at UMDF Mitochondrial Medicine 2022 Symposium

Retrieved on: 
Friday, June 10, 2022
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CAMBRIDGE, Mass., June 10, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced positive topline data in its signal-seeking clinical study of CY6463, for the potential treatment of Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). Chad Glasser, Pharm.D., Director of Clinical Research at Cyclerion Therapeutics, will present results from this clinical study today during the Clinical Trial Updates Panel at the United Mitochondrial Disease Foundation (UMDF) Mitochondrial Medicine 2022 Symposium, taking place June 8-11, 2022, in Phoenix, Arizona.

Key Points: 
  • Chad Glasser, Pharm.D., Director of Clinical Research at Cyclerion Therapeutics, will present results from this clinical study today during the Clinical Trial Updates Panel at the United Mitochondrial Disease Foundation (UMDF) Mitochondrial Medicine 2022 Symposium , taking place June 8-11, 2022, in Phoenix, Arizona.
  • The positive data from this study further support the potential of CY6463, the first and only CNS-penetrant sGC stimulator in clinical development, to provide therapeutic benefit to people living with MELAS.
  • We are excited by the strength of these data and consistency across disease domains, which support the further advancement of CY6463 as a potential treatment option.
  • A video presentation of the topline data is available on the Investor page of the Cyclerion website.

Cyclerion Therapeutics to Share CY6463 MELAS Topline Study Results, CHOP to Present CY6463 Preclinical Data at UMDF Mitochondrial Medicine 2022 Symposium

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Monday, June 6, 2022
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CAMBRIDGE, Mass., June 06, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced participation in the United Mitochondrial Disease Foundation (UMDF) Mitochondrial Medicine 2022 Symposium taking place June 8-11, 2022, in Phoenix, Arizona. Chad Glasser, Pharm.D., Director of Clinical Research at Cyclerion Therapeutics, will share topline Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) clinical study data. The company also plans to issue a press release summarizing study results. In addition, Leonard Burg, Ph.D., from Dr. Marni Falk’s research laboratory in the Mitochondrial Medicine Frontier Program in the Division of Human Genetics in the Department of Pediatrics at Children’s Hospital of Philadelphia (CHOP) and University of Pennsylvania Perelman School of Medicine, will present a poster on preclinical data from a series of studies demonstrating functional improvement in zebrafish mitochondrial disease models treated with CY6463.

Key Points: 
  • Chad Glasser, Pharm.D., Director of Clinical Research atCyclerion Therapeutics, will share topline Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) clinical study data.
  • The company also plans to issue a press release summarizing study results.
  • Cyclerion is advancing novel, first-in-class, CNS-penetrant, sGC stimulators that modulate a key node in a fundamental CNS signaling pathway.
  • For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn ( www.linkedin.com/company/cyclerion ).

Cyclerion Announces CY6463 Clinical Pipeline Progress and First Quarter 2022 Financial Results

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Wednesday, May 4, 2022
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CAMBRIDGE, Mass., May 04, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, announced today clinical development progress for CY6463, its lead program, and first quarter 2022 financial results.

Key Points: 
  • We have recently closed enrollment on our CY6463 studies in MELAS and CIAS and look forward to obtaining topline clinical data from these exploratory studies in Q2 and Q3 2022, respectively.
  • We have also continued to enroll our CY6463 study in Alzheimers Disease with vascular pathology, while efficiently driving Cyclerions earlier stage research programs forward.
  • The MELAS trial ( NCT04475549 ) is an open-label, single-arm study of oral, once-daily CY6463 in adults aged 18 or older with MELAS.
  • Net Loss: Net loss was approximately $13.0 million for the first quarter of 2022, as compared to $13.4 million for the first quarter of 2021.

Cyclerion Announces CY6463 Clinical Pipeline and Corporate Updates

Retrieved on: 
Thursday, February 24, 2022
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CAMBRIDGE, Mass., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, announced today clinical development updates for CY6463, its lead program, and additional corporate progress.

Key Points: 
  • We have recently closed enrollment on the MELAS study, and we look forward to sharing clinical results in Q2 2022.
  • We also continue to progress our other ongoing CY6463 exploratory studies, including in CIAS, and our recently initiated ADv study.
  • The Phase 2a MELAS trial ( NCT04475549 ) is an open-label, single-arm study of oral, once-daily CY6463 in adults aged 18 or older with MELAS.
  • Bruce Kinon, MD has joined Cyclerion as Vice President, Clinical Development and is leading the ongoing CY6463 clinical efforts.

Cyclerion Therapeutics Announces Initiation of Patient Dosing in CY6463 Phase 2a Study in Alzheimer’s Disease with Vascular Pathology

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Wednesday, January 26, 2022
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Furthermore, a Phase 1 study in elderly subjects demonstrated an impact on biomarkers relevant to neurodegeneration and cognitive impairment.

Key Points: 
  • Furthermore, a Phase 1 study in elderly subjects demonstrated an impact on biomarkers relevant to neurodegeneration and cognitive impairment.
  • The ongoing Phase 2a study will focus on a segment of the Alzheimers disease population where we believe our therapeutic candidate has the best opportunity to provide a clinical benefit.
  • The Phase 2a ADv study (NCT04798989) is a randomized, placebo-controlled study of oral once-daily CY6463 in approximately 30 participants over a twelve-week dosing period.
  • Study participants must have confirmed Alzheimers disease pathology as assessed by PET or CSF biomarkers, cardiovascular risk factors, as well as mild-to-moderate subcortical small-vessel disease as assessed by MRI.