Cyclerion Therapeutics is a biopharmaceutical company focused on developing innovative treatments for serious diseases, leveraging a robust scientific foundation and a collaborative approach. The company emphasizes a "best-owner" strategy for its compounds, allowing for independent development and commercialization or partnerships that enhance global patient access to their drugs. Cyclerion's leadership team and board of directors bring extensive experience in drug discovery and development, particularly in the central nervous system (CNS) disorders, which informs their strategic decisions and capital allocation to maximize shareholder value.

The company actively engages with external collaborators, including leading experts and advisory boards, to enhance its drug-hunting capabilities and clinical trial designs. This collaborative network is crucial for identifying unmet medical needs and advancing their therapeutic programs. Cyclerion's commitment to innovation is reflected in its culture and operational strategies, which aim to create impactful solutions for patients while ensuring financial prudence and growth for stakeholders.

United States

Cyclerion Therapeutics is a clinical-stage biopharmaceutical company applying neurological insights to discovery, develop, and commercialize innovative medicines for people with serious diseases of the central nervous system (CNS). Lead programs include 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).


Cardiovascular Diseases

Central Nervous System (CNS)

Kidney Diseases

Psychological Diseases

Cyclerion Therapeutics

Alzheimer's disease

Dementia

Neurological disorder

CY6463 (previously IW-6463), a CNS-penetrant sGC stimulator, is being developed as a potentially disease modifying therapy for neurodegenerative diseases. Nitric oxide is one of several&nbsp;fundamental&nbsp;neurotransmitters, one that has yet to be&nbsp;leveraged&nbsp;for its therapeutic potential in the CNS.&nbsp;sGC&nbsp;stimulators work&nbsp;synergistically with the nitric oxide naturally produced in the body to boost the positive effects of nitric oxide, even when the body is not producing enough. There are clear links between nitric oxide signaling defects and neurodegenerative diseases. Evidence indicates that endothelial cell loss and nitric oxide dysregulation are contributors to neurodegenerative diseases and result in reduced blood flow, vascular leakage, inflammation, and neuronal dysfunction/loss. sGC&nbsp;is&nbsp;expressed&nbsp;widely throughout the&nbsp;CNS and CNS vasculature. In preclinical studies, IW-6463 has been associated with increased cerebral blood flow, reduced markers of neuroinflammation, improved neuronal health, neuroprotective effects and enhanced cellular bioenergetics and mitochondrial function.

Zagociguat (CY6463)

Cognitive Impairment Associated with Schizophrenia

Mitochondrial disease

Rare diseases

Rare genetic disease

Sickle cell disease

Olinciguat is an oral, once-daily, vascular sGC stimulator that has been studied clinically in sickle cell disease. Olinciguat demonstrates broad pharmacology including effects on vascular function, inflammation, and fibrosis in multiple preclinical models, including those for pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Clinical studies have demonstrated a well-tolerated dose range, dose-proportional pharmacokinetics, and target engagement. In the Phase 2 STRONG-SCD study, olinciguat was generally well tolerated across all dose levels but did not demonstrate adequate activity to support further internal clinical development in this indication. Olinciguat has potential for use in indications such as PAH where the sGC mechanism has been clinically validated.

Olinciguat

Heart disease

Praliciguat is an oral, once-daily, systemic sGC stimulator designed for the treatment of serious cardiovascular and renal diseases.&nbsp; In preclinical studies, praliciguat demonstrated extensive distribution to key target tissues including adipose tissue, kidney, heart, and liver; the extensive, extra-vascular distribution of praliciguat has been confirmed in clinical studies. We believe this is fundamental to its potential to be a breakthrough therapy for cardiometabolic diseases characterized by adipose inflammation and metabolic dysfunction and associated with multi-organ etiology and involvement. Praliciguat has been studied clinically on top of standard of care in heart failure with preserved ejection fraction (HFpEF) and diabetic kidney disease (DKD).&nbsp; In both patient populations, praliciguat was well tolerated and demonstrated target engagement and effects on metabolic parameters. In the DKD study, treatment with praliciguat was associated with improvements in urinary albumin creatinine ratio, a marker of kidney damage. Praliciguat has demonstrated beneficial effects in a wide variety of renal and cardiometabolic animal models.

Cyclerion Therapeutics

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