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Cyclerion announces IW-6463 phase 1 healthy volunteer study results that support further development for neurodegenerative diseases
– Results in 110 subjects demonstrate favorable safety, CNS pharmacokinetics, and evidence of target engagement – – Study underway in elderly subjects to
About this update from Cyclerion Therapeutics, Inc.
[{"type":"text","content":"– Results in 110 subjects demonstrate favorable safety, CNS pharmacokinetics, and evidence of target engagement –\n – Study underway in elderly subjects to further assess cerebral blood flow and additional translational measures of CNS target engagement; topline readout anticipated in mid-2020 – – Company will present, with webcast, at the J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 9AM PST (noon EST) – CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), today announces positive Phase 1 study results that provide the foundation for continued development of IW-6463, an oral, once-daily central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator for the treatment of serious neurodegenerative diseases. The nitric oxide pathway and sGC stimulation have long been known to be a central physiological regulator in the central nervous system, impacting cerebrovascular blood flow, neuroinflammation, neuronal function and metabolism. “Our Phase 1 healthy volunteer study results indicate that IW-6463 was well tolerated. Pharmacokinetic (PK) data, obtained from both blood and cerebral spinal fluid (CSF), support once-daily dosing with or without food and demonstrate IW-6463 penetration across the blood-brain-barrier at levels expected to be pharmacologically active. We are excited about the therapeutic possibilities for IW-6463 as a first-in-class, brain penetrant sGC stimulator,” said Chris Wright, M.D., Chief Medical Officer of Cyclerion. “These results, together with our preclinical data, provide strong support for continued development of IW-6463 as a potential new medicine for serious neurodegenerative diseases.” Phase 1 Study Design and Topline Results The company’s first IW-6463 Phase 1 study was conducted in 110 healthy volunteers aged 18-63 years to evaluate safety and pharmacokinetics in blood and CSF. The three-stage study evaluated: a) single ascending doses, b) multiple ascending doses (over 14 days) and c) food interaction effects. Study results demonstrated that IW-6463 was well tolerated across the tested dose levels. The most common adverse events (AEs) observed in the active treatment group were headache, nausea, dizziness, somnolence and fatigue. All AEs were mild and no serious adverse events (SAEs) were observed. IW-6463 administra...