Research & Development
FDA withdraws complete Clinical Hold on Inhibikase Therapeutics' IkT-148009 in Multiple System Atrophy
9 March 2023 -

Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company, announced on Wednesday that the US Food and Drug Administration (FDA) has withdrawn the complete Clinical Hold on IkT-148009, the company's c-Abl inhibitor, in Multiple System Atrophy (MSA).

This move is intended to enable the firm to proceed with its plans for a future Phase two clinical trial in MSA.

The company said that 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. In previously published work, Inhibikase has demonstrated that MSA may also be initiated by c-Abl modification of alpha-synuclein aggregates in the brain. In ongoing animal models of MSA, Inhibikase has observed that IkT-148009 shows a substantial neuroprotective benefit, preventing functional loss in mice following 7 week, once-daily dosing. The company will continue to evaluate the functional benefit of IkT-148009 for an additional 3 months in order to assess whether IkT-148009 leads to clearance of alpha-synuclein aggregate pathology in the treated animals.

The planned '202' trial will evaluate the safety, tolerability and pharmacokinetics of IkT-148009 in MSA patients over 6 months of once daily dosing at one of two oral doses.