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Inhibikase Climbs on FDA Nod Inhibikase Therapeutics, Inc. (NASDAQ: IKT) shares gathered steam early Wednesday, as the company, a clinical-stage pharmaceutical firm developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration has lifted the full Clinical Hold on IkT-148009 in Parkinson's disease (PD).
IkT-148009 is a c-Abl tyrosine kinase inhibitor that has been shown to halt disease progression, protect and restore lost neurons and to clear the underlying protein pathology in animal studies that suggests a causal link to the initiation and progression of disease in humans1. In lifting the clinical hold, the Agency based their decision on the Company's Complete Response and Amendment dated December 21, 2022, as well as further commitments made on January 20, 2023 regarding ophthalmologic monitoring in the protocol of study IkT-148009-201 and various modifications to the Investigator Brochure.
Said CEO Milton Werner, 'We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in PD.
'We believe that we now have clarity on the FDA's expectations as we move forward in the 201 clinical trial for IkT-148009. We are now working to re-open clinical trial sites and initiate screening and enrollment of patients for the trial following agreed upon updates to the Protocol and Informed Consent form. We anticipate completing these restart tasks by the end of the first quarter.'
IKT shares tacked on 11 cents, or 12.1%, to $1.02
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