Inhibikase Therapeutics Announces Final Pre-IND Meeting Outcomes For IkT-001Pro For Pulmonary Arterial Hypertension
- FDA indicated IkT-001Pro can be considered a New Molecular Entity and is eligible for exclusivity designations in Pulmonary Arterial Hypertension –
BOSTON and ATLANTA, May 09, 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 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.
"Following our pre-IND discussion with the FDA related to the chemical entity status and path to approval for Pro as a treatment for Pulmonary Arterial Hypertension, the FDA confirmed in final meeting minutes that Pro would be considered a New Molecular Entity (NME) in PAH," said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. "This designation opens the path to patent and NME exclusivity for IkT-001Pro even though the FDA agreed that the 505(b)(2) path is appropriate for approval. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication of high unmet medical need. PAH is a rapidly progressing, often fatal disease affecting primarily women between the ages of 30 and 60. There are several products on the market that address symptoms of the disease, but only one disease-modifying therapy has been approved to date. In previous clinical trial work, imatinib, the active ingredient in Pro, demonstrated that it could be disease-modifying for PAH. We believe that Pro has the potential to be a safer and better tolerated therapeutic option for imatinib treatment and are actively pursuing partnership discussions to advance Pro into clinical development."