regulatory
confidence high
sentiment positive
materiality 0.80
FDA lifts full clinical hold on Inhibikase's IkT-148009 for Parkinson's; Phase 2a trial restarting
Inhibikase Therapeutics, Inc.
- FDA lifted full clinical hold on IkT-148009; Phase 2a 201 trial resumes at 50 and 100 mg doses.
- Company will measure safety and steady-state PK of 200 mg in 6 healthy subjects before PD patient dosing.
- Expanded ocular monitoring includes cornea/lens; no ocular pathology observed to date.
- Inhibikase intends to seek lift of clinical hold on its Multiple System Atrophy (MSA) program.
- Publication in Science Translational Medicine shows IkT-148009 halts neurodegeneration and reduces alpha-synuclein pathology in mouse models.