Inhibikase Therapeutics, Inc. 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 (FDA) for IkT-001Pro (?Pro?) as a candidate treatment for Pulmonary Arterial Hypertension (PAH). Following review of the final meeting minutes, Inhibikase is preparing the Investigational New Drug (IND) 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.

Pulmonary Arterial Hypertension is a rare disease of the pulmonary microvasculature. PAH can arise spontaneously, or can be caused by genetic mutations, drugs or environmental toxins. PAH is also associated with connective tissue disease (CTD), congenital heart disease and HIV infection.

Most treatments for PAH attempt to address symptoms of this progressive disorder, but the recent approval of Winrevair® highlights that disease-modification is possible. There are approximately 30,000 cases of PAH in the U.S. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030.