Inhibikase Therapeutics, Inc. announced that the Company will meet with the Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) in the Division of Cardiology and Nephrology (DCN) at the U.S. Food and Drug Administration (FDA) for a Pre-IND meeting to discuss IkT-001Pro (?Pro?) as a treatment for Pulmonary Arterial Hypertension (PAH). The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes. 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, HIV infection and other insults that could affect the right side of the heart. 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. Imatinib has been shown to have efficacy on par with Winrevair® (doi: 10.1164/rccm.201001-0123OC), however its side effect profile precluded approval in this patient population. Changes in the standard-of-care for these patients suggests that the serious adverse events which arose from treatment with imatinib mesylate in the 2010s may not occur when imatinib is delivered as IkT-001Pro; the Company has yet to conduct any clinical studies to validate this hypothesis.

The Pre-IND meeting will review our proposed late-stage trial design to reproduce efficacy and evaluate the safety and tolerability of imatinib delivered by IkT-001Pro in patients with WHO Class I PAH, as well as seek regulatory advice or clarity on FDA orange book exclusivity, approval pathways, special designations. Based on the meeting outcome, the Company will evaluate whether to proceed with filing the IND for IkT-001Pro in this indication and undertake a strategic review and business development initiative to define the Company?s path forward with this product.