Ironwood Pharmaceuticals has commenced a Phase I trial investigating IW-6463 for the treatment of central nervous system (CNS) disorders.

IW-6463 is an orally administered CNS-penetrant soluble guanylate cyclase (sGC) stimulator that is currently under development for use in the treatment of serious and orphan CNS disorders.

The solution is being developed by Cyclerion Therapeutics, which is expected to be separated from Ironwood in the first half of this year.

The placebo-controlled, double-blind trial is designed to evaluate the safety, tolerability, and pharmacokinetics of oral IW-6463 in healthy participants.

“We believe IW-6463 may represent an important option for the treatment of serious neurodegenerative diseases.”

Both the single-ascending and multiple-ascending doses of IW-6463 are expected to be studies as part of the randomised Phase I trial.

Data from the trial is expected to be available in the second half of this year.

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Cyclerion Therapeutics development head and Ironwood Pharmaceuticals incoming chief medical officer Chris Wright said: “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 I 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.”

CNS disorders are a set of neurological diseases that affect the structure or function of the brain or spinal cord, all of which form the CNS.