Nature of Business |
9 Months Ended |
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Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business |
1.
Nature of Business
Inhibikase Therapeutics, Inc. (the “Company,” “we” or “our”) is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases. The Company’s multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program utilizing Risvodetinib (IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases, targets the treatment of Parkinson’s disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. In 2021, we commenced clinical development of Risvodetinib (IkT-148009), which we believe can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI. In January, 2023, the Company initiated its Phase 2 program for Risvodetinib (IkT-148009) as a treatment for Parkinson’s disease. As of the date of this Report, 28 sites are open and actively evaluating prospective trial participants and 20% of the trial has been enrolled. In March 2023, the Company opened its IND for Risvodetinib (IkT-148009) as a treatment for the orphan disease Multiple System Atrophy or MSA. In October 2023, the Company received Orphan Drug Designation for Risvodetinib (IkT-148009) as a treatment for MSA. The Company is also developing platform technologies for alternate ways to deliver protein kinase inhibitors in patients. Our first example of this technology is IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, to treat Stable Phase Chronic Myelogenous Leukemia (SP-CML). Pursuant to its IND, which was cleared by the FDA in August 2022, IkT-001Pro has completed a three-part dose finding/dose equivalence study in up to 66 healthy volunteers (the 501 trial). The study was designed to evaluate the 96-hour pharmacokinetics of imatinib delivered as IkT-001Pro and determine the dose of IkT-001Pro that can deliver imatinib equivalent to either 400 mg or 600 mg imatinib mesylate. With the completion of the 501 study, Inhibikase will submit briefing materials to the FDA and seek agreement on the requirements for the New Drug Application (“NDA”) process following the proposed approval path for IkT-001Pro under the 505(b)(2) statute. |