Inhibikase Therapeutics has commenced dosing of the first subject in the Phase Ib clinical trial of its drug, IkT-148009, to treat Parkinson’s disease, a neurodegenerative disorder that is progressive.
IkT-148009 is an inhibitor of Abelson Tyrosine Kinase or c-Abl, a clinically established target that is triggered on affected neurons in the brain and gut internalising plaques of alpha-synuclein.
The randomised, placebo-controlled Phase Ib extension trial will analyse the safety, pharmacokinetics and tolerability of IkT-148009 in Parkinson’s patients assessed over seven to 14 days.
It will have 24 subjects categorised into a 3:1 ratio to receive one of the three escalating doses of IkT-148009.
Inhibikase previously submitted the interim 13-week toxicology study data to the US Food and Drug Administration, which subsequently reviewed and accepted the firm’s plans to dose subjects for three months.
Exploratory goals of the trial will include cognitive and motor function, as well as gut motility and alpha-synuclein aggregate clearance measures in various compartments.
Inhibikase Therapeutics president and CEO Milton Werner said: “This is the first time we will assess our selective c-Abl kinase inhibitor in Parkinson’s patients, which could give us an early look into the potential efficacy of this treatment in slowing or possibly halting disease progression and even partly restoring functional loss in Parkinson’s disease.
“As we look ahead, we anticipate completing this study and advancing into a Phase IIa study in 2022.”
According to data from the Phase I trial in 56 healthy elderly subjects, IkT-148009 attained greater drug exposure between 12.5-100mg without any clinically substantial adverse events reported.
These findings were in line with exposures noted in animal efficacy trials of inherited, as well as sporadic progressive Parkinson’s disease.