Inhibikase Therapeutics Announces FDA Cli... - Cure Parkinson's
Inhibikase Therapeutics Announces FDA Clinical Hold on IkT-148009 Programs
This kind of thing usually result of a serious unexpected adverse event in a trial. The company says they are unaware of such. I suppose the FDA will explain in due course.
Upon reading this I was wondering if this might have something to do with this:
Inhibikase's preclinical pipeline consists of IkT-001Pro, which is being developed as an alternative to Novartis’ Abelson tyrosine kinase inhibitor Gleevec, which is approved for chronic myelogenous leukemia and gastrointestinal stromal tumors, among others. Inhibikase's research covers two small molecules being explored for dementia and a brain disease called progressive multifocal leukoencephalopathy.
inhibikase.com/news/press-r...
"While the FDA clinical hold on our IkT-148009 programs for Parkinson's disease and Multiple System Atrophy was unexpected, we are actively working with the agency to understand their concerns and resolve them as soon as possible. To date we have not seen any serious adverse events in our Phase 2a '201' trial and believe the recently presented results from our Phase 1/1b '101' trial continues to support the safety, tolerability and pharmacokinetics of IkT-148009," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we work to resolve the clinical hold, we remain on track to initiate the '501' bioequivalence study to evaluate IkT-001Pro for the treatment of stable phase Chronic Myelogenous Leukemia in the fourth quarter. In addition, we will continue to gather preclinical data for IkT-148009 in MSA and expect to advance a second animal model study in the fourth quarter. We remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases and look forward to providing updates as appropriate."
The FDA indicated it will provide an official clinical hold letter to Inhibikase within 30 days to explain the reason for this action. To date, the Company has dosed eleven patients in the trial and will conduct a blinded safety assessment, but there have been no serious adverse events seen in the trial to date and only two mild adverse events have been recorded. Since none of the initial eleven patients completed the study, once the clinical hold is lifted, the study will need to be restarted.
