Grandbrothers/iStock Editorial via Getty Images Inhibikase Therapeutics (NASDAQ:IKT) stock rose ~12% on Wednesday after the company said that the U.S. Food and Drug Administration (FDA) lifted a clinical hold on IkT-148009 in Parkinson’s disease (PD). In November, the FDA had placed a clinical hold on the company’s IkT-148009 201 program in PD and the use of IkT-148009 in Multiple Systems Atrophy (MSA). The MSA program is still on hold. Inhibikase said on Wednesday that in lifting the clinical hold, the FDA based its decision on the company’s response in December 2022 and commitments made in January 2023 regarding ophthalmologic monitoring in the protocol of study IkT-148009-201 and various modifications to the Investigator Brochure. “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,” said Inhibikase’s President and CEO Milton Werner. The agency requested that the company measures the safety and steady-state pharmacokinetic (PK) profile of the 200 mg dose in six healthy people before administration of the 200 mg dose in patients with PD. The FDA also asked the measurement of visual acuity and examination of the cornea and lens to complement the analysis of retina, macula and fundus which was already part of the ocular monitoring program in the 201 trial, the company added. In addition, the U.S. drug regulator requested removal of safety-related data in the Investigator Brochure for the primary metabolites of IkT-148009 to give the agency time to review the report in support of this safety data. Inhibikase noted that it plans to seek a lifting of the clinical hold on its program focused on MSA.
