On June 5, 2024 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 ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported expansion of its therapeutic pipeline and multiple updates to its Research and Development programs.
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"At Inhibikase we have let fundamental scientific discoveries drive identification of new product candidates that could transform the lives of patients. We first began clinical development of our product candidates in 2021. In 2025, we anticipate having multiple late-stage ready assets across our therapeutic pipeline," commented Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "The 201 Trial in untreated Parkinson’s disease has reached 94% enrollment and we anticipate enrolling the last patient in mid-June. In parallel, we are seeking grant funding for the 202 trial in Multiple System Atrophy through The National Institute of Neurological Diseases and Stroke (NINDS). Finally, following our pre-IND meeting with the U.S. Food and Drug Administration (FDA) in April, 2024, we have made the decision to redirect our efforts with IkT-001Pro into cardiopulmonary disease, opening a new therapeutic area for the Company. Taken together, we believe we are on track to advance our clinical assets into late-stage trials in the coming year."
Upcoming Milestones and Strategic Updates:
Complete The 201 Trial in untreated Parkinson’s disease. The Company anticipates that the last patient will complete the 12-week treatment period before the close of the third quarter of 2024. The Company expects to report biomarker and outcome data to support the Company’s pursuit of an End of Phase 2 and Phase 3 protocol discussion with the FDA by the end of 2024.
Expansion into cardiopulmonary disease. Following the Company’s pre-IND meeting with the FDA, the Company will submit its IND application to the FDA for IkT-001Pro as a treatment for Pulmonary Arterial Hypertension (PAH) early in the third quarter of 2024, opening a new therapeutic area for the Company. The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that 001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for indication of high unmet need. The IND for 001Pro in PAH represents the seventh the Company has filed since 2019.
Scaling manufacturing of IkT-001Pro. Following the Company’s pre-NDA meeting with the FDA in January, 2024, the Company is scaling its process development efforts for IkT-001Pro to support late-stage clinical development and NDA batch requirements. These activities include development of new dosage forms to differentiate 001Pro tablets from generic imatinib mesylate in alignment with FDA feedback.
Seeking support for the 202 Trial in Multiple System Atrophy through the Other Transaction Authority of NINDS. The National Institute of Neurological Diseases and Stroke (NINDS) is initiating a new funding mechanism for clinical development in neuroscience beginning June, 2024. Through this new program, termed the Other Transaction Authority (OTA), the Company is seeking to support its Phase 2 ‘202 Trial’ in MSA trial using a dedicated U.S. trial network set-up by the Institute.
Discontinuing antiviral development for Progressive Multifocal Leukoencephalopathy (PML): As part of the Company’s strategy to focus on late-stage clinical assets in neurodegeneration, cancer and cardiopulmonary disease, Inhibikase will discontinue development of treatments for PML.