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Inhibikase Says FDA Clears IND For IkT-001Pro To Treat Chronic Myelogenous Leukemia
(RTTNews) - Pharmaceutical company Inhibikase Therapeutics, Inc. (IKT) announced Friday 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.
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).
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.
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.
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