The Company is evaluating cerebrospinal fluid and plasma biomarkers and various imaging approaches to define optimal clinical endpoints. 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 programs include praliciguat which recently completed Phase 2 studies and which the company intends to out-license for further development in diabetic nephropathy, olinciguat in Phase 2 development for sickle cell disease, IW-6463 in Phase 1 development for serious CNS diseases, and two preclinical programs targeting serious liver and lung diseases, respectively. Upon red blood cell rupturing, nitric oxide is depleted due to arginase release and hemoglobin scavenging. In preclinical studies, our lead CNS drug candidate, IW-6463, has shown beneficial effects across several distinct domains relevant to neurodegenerative diseases and we believe this molecule holds promise to improve the lives of patients with Alzheimer's disease and other serious CNS conditions. Schulman brings extensive leadership in the pharmaceutical and biotechnology industries, including commercial strategy, corporate development, strategic transactions and capability building. 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 IW-6463, a CNS-penetrant sGC stimulator, is being developed as a symptomatic and potentially disease modifying therapy for neurodegenerative diseases.
We also continue discussions on the out-licensing of praliciguat, a potential best-in-class therapeutic candidate for cardio-metabolic diseases. These sickled red blood cells are more susceptible to hemolysis (rupturing).
The study will evaluate safety and biomarker measures of CNS activity. We are taking a different approach; our Innovation Center gathers our deep expertise in research, in development, in customer insights, and in external innovation together in one team, where we work together to optimize our drug candidates as we strive to make them into innovative products that address unmet medical needs in a complex commercial environment. The nitric oxide pathway and sGC stimulation have long been known as central physiological regulators in the CNS, affecting cerebrovascular blood flow, neuroinflammation, neuronal function and cellular bioenergetics.In January 2020, the Company reported encouraging Phase 1 healthy volunteer study An ongoing translational pharmacology clinical study has enrolled 24 elderly subjects. Mr. McGuire also serves on the boards of Adimab and Direct Vet Marketing (Vets First Choice), among others. We look forward to the top line results in Q3 2020 and to making a data-driven decision regarding advancement to the next phases of development," said Chris Wright, M.D., Cyclerion… These results are intended to enable Cyclerion to direct further development in high-value CNS indications where biological and genetic data suggest an important role for nitric oxide and cyclic guanosine monophosphate (cGMP) signaling.Cyclerion will discuss IW-6463 and its CNS program, along with its diabetic nephropathy and sickle cell disease clinical programs, at the J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020. Our intent is to apply this to our development approach so that we may efficiently assess potential therapeutic benefits and determine how to optimally approach future clinical studies," said Dr. Cyclerion expects top-line clinical results in mid-2020.With supportive study results, the Company plans to direct further development towards serious CNS diseases with high unmet medical need where biological and/or genetic data suggest an important role for nitric oxide and cyclic guanosine monophosphate (cGMP) signaling.In October 2019, the Company announced encouraging topline Cyclerion continues to engage in discussions to out-license praliciguat for late-stage global development and commercialization as a potentially best-in-class therapeutic for cardiometabolic diseases.Olinciguat is an investigational, orally-administered, once-daily, vascular sGC stimulator for the potential treatment of sickle cell disease (SCD).
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