Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia

BOSTON and ATLANTA, Aug. 26, 2022 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), 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 U.S. Food and Drug Administration (FDA) has reviewed its Investigational New Drug (IND) application for IkT-001Pro for the treatment of Chronic Myelogenous Leukemia (CML) and issued a Study May Procced (SMP) letter.
Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia
IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that occur from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. IkT-001Pro has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major and/or complete cytogenetic responses in stable-phase CML. In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer than imatinib in non-human primates, reducing burdensome gastrointestinal side effects that occur following oral administration. Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for stable-phase CML in September, 2018."We are excited to have received the SMP letter from the FDA for IkT-001Pro for CML. This represents the first program to emerge from our novel prodrug platform, which aims to improve the safety and tolerability of approved and novel therapeutics," commented Milton H. Werner, Ph.D., President and Chief Executive Officer. "Based on preclinical studies, we believe that IkT-001Pro has the potential to significantly improve the safety profile of oral imatinib, which may enhance patient adherence and quality of life, potentially leading to better rates of complete cytogenetic response. We look forward to initiating a bioequivalence study in the second half of 2022."IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and will enroll approximately 64 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses. The study is designed to evaluate the safety profile of IkT-001Pro as well as identify a dose with a similar systemic exposure and pharmacokinetic profile compared to 400 mg imatinib mesylate at 96 hours post administration. Following this study, Inhibikase will conduct a superiority study comparing the selected dose of IkT-001Pro to 400 mg imatinib mesylate, the current standard-of-care for stable-phase Chronic Myelogenous Leukemia and evaluate the adverse event profile and patient reported outcomes as a measure of superiority over standard-of-care.
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