The FDA announced that it will lift the full Clinical Hold on IkT-148009, a c-Abl tyrosine kinase inhibitor that has shown promising results at stopping the progression of Parkinson’s disease in animal models.
A Phase 2a trial was underway to study 50-, 100-, and 200-mg doses of the compound when the FDA requested that Inhibikase Therapeutics, Inc. provide further data on the highest dose before testing it in patients with Parkinson’s. Inhibikase agreed to test the safety and pharmacokinetics of the 200-mg dose in six healthy volunteers as well as perform additional ocular monitoring in the trial, consistent with safety monitoring protocols in other trials of protein kinase inhibitors.
“We believe that we now have clarity on the FDA’s expectations as we move forward in the 201 clinical trial for IkT-148009,” stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics, who anticipates the trial will restart by the end of the first quarter. Inhibikase plans to work on lifting the Clinical Hold on its multiple system atrophy trial program as well.
Inhibikase also announced positive results from a preclinical trial of IkT-148009 in an animal model of inherited and sporadic Parkinson’s disease. The study, published in Science Translational Medicine, showed that IkT-148009 suppressed c-Abl, reduced levels of alpha-synuclein, and recovered motor function in a mouse model of Parkinson’s.
“Remarkably, therapeutic benefit in these models was accompanied by substantial reduction of alpha-synuclein pathology in the brain, a long-sought goal of Parkinson’s treatment,” said Werner.