Inhibikase Therapeutics has dosed the first patient in a Phase II ‘201’ clinical trial of IkT-148009 for the treatment of Parkinson’s disease.
Nearly 120 patients with untreated Parkinson’s disease and who are yet to receive symptomatic treatment will be enrolled in the study.
The double-blind study will randomise patients into a 1:1:1:1 ratio to receive either 50mg, 100mg or 200 mg of IkT-148009 against a placebo once daily for 12 weeks.
The primary endpoint of the study is to evaluate the safety, tolerability, and steady-state pharmacokinetics of IkT-148009.
Measuring a hierarchy of 15 Parkinson’s-related disease assessments in the brain and gut are the secondary endpoints of the study.
The study intends to use advanced assessments in skin and spinal fluid to measure the effect of treatment on pathological alpha-synuclein.
Inhibikase Therapeutics president and CEO Milton Werner said: “Dosing of the first patient in our ‘201’ trial completes the first milestone in our revamped Phase II programme evaluating the clinical benefit 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 more than one million people in the US annually.
“Our research has validated the critical role that c-Abl 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.”
A new Abelson Tyrosine Kinase (c-Abl) inhibitor IkT-148009 targets the treatment of Parkinson’s disease inside and outside the brain and other disorders arising from Abelson Tyrosine Kinase.