Other Clinical Assets

Cyclerion has deep expertise discovering and developing novel sGC stimulators for a wide variety of diseases.  As a CNS-focused company, we are out-licensing our non-CNS sGC stimulators for further development and commercialization. The most advanced in development are the oral, systemic sGC stimulators, praliciguat and olinciguat, which are described in greater detail below.  In addition, we have discovery-phase sGC stimulators that specifically target the liver and lung with the potential to treat serious hepatic and pulmonary diseases.  If you are interested in learning more, please email us at partnering@cyclerion.com.

Praliciguat is an oral, once-daily, systemic sGC stimulator designed for the treatment of serious cardiovascular and renal diseases.  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).  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.

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.