FDA Removes Regulatory Overhang From Inhibikase Therapeutics Parkinson/Atrophy Program

The FDA lifted the full Clinical Hold on Inhibikase Therapeutics Inc's IKT IkT-148009, the company's c-Abl inhibitor, in Multiple System Atrophy (MSA), allowing the company to proceed with its plans for a future Phase 2 clinical trial in MSA.
IkT-148009 is a potent, selective, brain-penetrant c-Abl tyrosine kinase inhibitor that has been shown to halt disease progression, protect and restore lost neurons and clear the underlying protein pathology in animal studies of Parkinson's disease.
MSA is a rare form of Parkinsonism, which occurs in a different part of the brain and advances three times faster than ordinary Parkinson's disease.
The planned '202' trial will evaluate the safety, tolerability, and pharmacokinetics of IkT-148009 in MSA patients over six months.
In January, the FDA lifted the full Clinical Hold on IkT-148009 in Parkinson's disease.
In December 2022, the FDA raised several points in its explanation of the basis for the clinical hold:
- Further evaluation of the existing safety and pharmacokinetic data and justification supporting the 200 mg dose used in Phase 2a '201' clinical trial.
- A better understanding of how the clinical trial will monitor the potential for detecting adverse events that could affect vision in trial participants and whether those adverse events are reversible.
Price Action: IKT shares are down 1.35% at $0.70 on the last check Wednesday.