Inhibikase Therapeutics announces pre-IND meeting with FDA for IkT-001Pro

Inhibikase Therapeutics announced that the Company will meet with the Office of Cardiology, Hematology, Endocrinology and Nephrology in the Division of Cardiology and Nephrology at the U.S. Food and Drug Administration for a Pre-IND meeting to discuss IkT-001Pro as a treatment for Pulmonary Arterial Hypertension. The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes. Imatinib has been shown to have efficacy on par with Winrevair, 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.