Inhibikase Therapeutics announced that the Company has received final meeting minutes from its recent pre-IND meeting with the Division of Cardiology and Nephrology of the U.S. Food and Drug Administration for IkT-001Pro as a candidate treatment for Pulmonary Arterial Hypertension. Following review of the final meeting minutes, Inhibikase is preparing the Investigational New Drug application. In the final minutes from the pre-IND meeting, the FDA agreed that Inhibikase had built a bridge between imatinib’s use in blood and gastrointestinal cancers and PAH and supported the Company’s Phase 2/3 design as the initial clinical pursuit. The FDA requested the Company complete a pre-clinical cell culture-based study of the hERG ion channel to compare Pro to imatinib as Imatinib has previously been linked with certain cardiovascular abnormalities. The Company intends to complete this 7-day experiment prior to an IND submission. In parallel, the Company has initiated discussions with potential strategic partners in order to advance the development of Pro for Pulmonary Arterial Hypertension.
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