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.

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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.