Ironwood Pharmaceuticals, Inc. announced the initiation of a Phase 1 study evaluating IW-6463 in healthy volunteers. IW-6463 is an orally administered central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator that is being developed for the treatment of serious and orphan CNS disorders. Data from the Phase 1 study are expected in the second half of 2019. The randomized, placebo-controlled Phase 1 clinical study is designed to assess the safety, tolerability, and pharmacokinetics of oral IW-6463 in healthy volunteers. The study will evaluate both single-ascending and multiple-ascending doses of IW-6463 in healthy subjects using a randomized, placebo-controlled, double-blind, sequential-group design. IW-6463 is one of five differentiated sGC stimulator programs expected to be advanced by Cyclerion, a clinical-stage biopharmaceutical company focused on breakthrough treatments for serious and orphan diseases. The separation of Ironwood and Cyclerion is on track to be completed in the first half of 2019.