FDA Clears IND for IkT-001Pro for the Treatment of CML

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for IkT-001Pro, a tyrosine kinase inhibitor and antineoplastic agent, for the treatment of chronic myelogenous leukemia (CML) and issued a Study May Proceed letter to the manufacturer of the drug.

The safety profile of IkT-001Pro, a prodrug formulation of imatinib mesylate, will be evaluated in a single ascending dose bioequivalence study, with approximately 64 healthy volunteers aged 25 to 55 years who will receive IkT-001Pro at one of four doses. The study will also identify a dose with a similar systemic exposure and pharmacokinetic profile compared to imatinib mesylate 400 mg at 96 hours post-administration.

A superiority study will follow that will compare the selected dose of IkT-001Pro to imatinib mesylate 400 mg, the current standard of care for stable-phase CML, and evaluate the adverse event profile and patient-reported outcomes as measures of superiority over standard of care.

Source: PR Newswire, August 2022