United States-based Ironwood Pharmaceuticals has started a phase one study assessing IW-6463 in healthy volunteers, it was reported yesterday.
The product 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. It 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.
The randomised, placebo-controlled Phase one clinical study is designed to evaluate the safety, tolerability, and pharmacokinetics of oral IW-6463 in healthy volunteers. The study will assess both single-ascending and multiple-ascending doses of IW-6463 in healthy subjects using a randomised, placebo-controlled, double-blind, sequential-group design. Data from the Phase one study should be revealed in the second half of 2019.
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