Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension

Meeting to discuss potential of IkT-001Pro as a disease modifying treatment for Pulmonary Arterial Hypertension

BOSTON and ATLANTA, April 03, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today 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.

“Following our pre-NDA discussion with the FDA related to the path to approval for IkT-001Pro in up to 11 blood and stomach cancers in January, we requested an additional FDA meeting with the Division of Cardiology and Nephrology to discuss Pro as a treatment for Pulmonary Arterial Hypertension,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. “PAH is a rare condition that primarily afflicts women between the ages of 30 and 60 and can lead to premature heart failure and death. Previous clinical research with imatinib, the active ingredient in Pro, was shown to be potentially disease-modifying for PAH, however, the adverse event profile of imatinib mesylate in this patient population could not support approval by the FDA. We believe that Pro may be a be a safer and better tolerated therapeutic option for imatinib treatment in PAH. We look forward to the FDA’s input on a proposed late-stage trial design and to the FDA’s viewpoint on if Pro could be treated as a branded product for this indication.”

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.