Inhibikase Therapeutics has dosed the first subject in the Phase IIa 201 clinical trial of IkT-148009 to treat Parkinson’s disease.

The double-blind, randomised, 12-week dosing trial will analyse IkT-148009’s safety, tolerability, and steady-state pharmacokinetics as primary endpoints.

It will enrol nearly 120 untreated Parkinson’s disease patients who have not so far advanced to require symptomatic therapy.

Subjects will be categorised into a 1:1:1:1 ratio to receive either 50mg, 100mg or 200mg given a once-a-day dose of IkT-148009 or a placebo.

A hierarchy of Parkinson’s-linked disease evaluations in the brain and gut will be analysed as the trial’s secondary or exploratory endpoints.

At present, the trial is screening subjects at 12 of the 40 planned sites in North America, with the further launch of sites underway on a rolling basis.

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A selective inhibitor of Abelson Tyrosine Kinase (c-Abl), IkT-148009 hinders c-Abl and the closely linked Abl2/Arg enzyme, without inhibiting other Abl-kinase family members such as c-Kit or PDGFRa/b.

According to preclinical findings in animal models of human Parkinson’s, the therapy showed to offer functional recovery in under eight weeks in animals.

Inhibikase Therapeutics president and CEO Milton Werner said: “Dosing of the first patient in our Phase IIa ‘201’ trial represents a major milestone in the development of IkT-148009 for the treatment of Parkinson’s disease and related disorders.

“Parkinson’s disease remains one of the most prevalent neurodegenerative disorders and affects nearly one million people in the US annually.

“Our research continues to validate the critical role that c-Abl, a mechanistically defined target, plays in the initiation and progression of Parkinson’s disease, as well as the potential of IkT-148009 as a promising new approach to disease modification.”