Inhibikase Therapeutics, Inc. announced that it has selected the bioequivalent dose of IkT-001Pro, the Company's prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevec(R)) in patients with Chronic Myelogenous Leukemia (CML) and provided an update on its '501' bioequivalence study. The '501' bioequivalence study has evaluated IkT-001Pro at four single ascending doses of 300, 400, 500 and 600 mg, leading to the selection of 600 mg IkT-001Pro as the bioequivalent dose to 400 mg imatinib mesylate. The pivotal phase of the study was dosed with bioequivalent IkT-001Pro in 31 healthy volunteers; one subject was excluded pre-dose due to aberrant clinical laboratory values.

The Company expects to complete the pivotal clinical phase of the study by the end of the second quarter. Following the completion of the '501' trial, Inhibikase will initiate a discussion with the FDA on the parameters for approval of IkT-001Pro under the 505(b)(2) statute.