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Inhibikase Therapeutics Announces Final Pre-IND Meeting Outcomes for IkT-001Pro as a Treatment 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.” 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 an 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. About Inhibikase (www.inhibikase.com) Social Media Disclaimer Forward-Looking Statements Contacts: Company Contact: Investor Relations: |