Pharma Focus Europe

Inhibikase Therapeutics Provides Update to FDA Clinical Hold of IkT-148009 Programs

Thursday, December 08, 2022

Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, announced that it has received the U.S. Food and Drug Administration's (FDA) clinical hold letter in regards to the Company's IkT-148009 programs in Parkinson's disease and Multiple System Atrophy.

The FDA raised several points, summarized below, in their explanation of the basis for the clinical hold:

  • Further evaluation of the existing safety and pharmacokinetic ("PK") data and justification supporting the use of the 200 mg dose used in the 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.
  • Need for material additions to the disclosures made to investigators and patients related to the clinical and safety measures completed to date, including the potential risks to vision in trial participants.

"We have reviewed the FDA's clinical hold letter and we will be responding to the issues cited in the letter in the coming days," said Milton Werner, Ph.D., President and Chief Executive Officer. "The FDA is seeking additional supportive information for the selection of the 200 mg dose in the '201' trial.  In addition to the Phase 1b '101' trial data and the rationale for dose selection and vision monitoring in the '201' trial we reviewed with the FDA, the FDA will also receive the unblinded safety, tolerability and pharmacokinetic data from the first 11 patients in the '201' trial, including safety and pharmacokinetic data from three patients dosed at 200 mg in the '201' trial.  We believe that the safety, tolerability and pharmacokinetic data measured to date support the continued development of IkT-148009 and restart of the '201' trial.  We look forward to a resolution with the FDA and lifting of the clinical hold soon as possible."

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