FDA lifts clinical hold on Inhibikase Therapeutics Parkinson’s trial

Jan. 25, 2023

Atlanta-based biotech Inhibikase Therapeutics announced this week that the FDA has lifted the full clinical hold on its Parkinson’s disease (PD) phase 2 drug trial.

The tyrosine kinase inhibitor, IkT-148009, is being studied for the treatment of PD and other related disorders of the Abelson Tyrosine Kinases, which have been known to drive inflammation, cancer and other pathologies.  

The FDA first placed the hold on Inhibikase's 201 clinical trial in December 2022, and asked that the company provide further justification supporting the dosage used, more information on how adverse events would be detected and managed and developed material additions to the disclosures made to patients on potential risk to vision. 

Now, based on the company’s Complete Response and Amendment, the agency is lifting the hold on the condition that Inhibikase measures the safety profile of the 200 mg dose in six healthy subjects prior to the administration of the 200 mg dose in Parkinson's patients. 

Additionally, the agency is asking that Inhibikase continues to measure visual acuity and cornea health.