Ironwood Pharmaceuticals Initiates Phase 1 Trial of IW-6463

Ironwood Pharmaceuticals 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 initiation of this Phase 1 study with IW-6463 marks an important milestone for our portfolio of next-generation sGC stimulators,” saidChris Wright, M.D., Ph.D., Ironwood’s current head of development and incoming chief medical officer and head of development of Cyclerion Therapeutics, Inc. (Cyclerion). “With its ability to cross the blood-brain-barrier, we believe IW-6463 may represent an important option for the treatment of serious neurodegenerative diseases, where there is a high unmet medical need. Our Phase 1 study is designed to provide safety, tolerability and pharmacokinetic data on single- and multiple-ascending doses of IW-6463, as well as to explore evidence of translation of some of our pre-clinical results on CNS activity in this first-in-human study.”

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.