Inhibikase Therapeutics Announces Selection of the Bioequivalent Dose of IkT-001Pro and Provides Update on the ‘501’ Bioequivalence Study

Inhibikase Therapeutics (IKT) Announces Selection of the Bioequivalent Dose of IkT-001Pro and Provides Update on the ‘501’ Bioequivalence Study

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, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today 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^®) 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.

“Based on the safety signals we have seen at the 600 mg dose of IkT-001Pro relative to 400 mg imatinib mesylate, we believe that we have identified the appropriate go-forward dose for standard-of-care treatment with IkT-001Pro,” stated Dr. Milton Werner, President and Chief Executive Officer of Inhibikase Therapeutics. “We plan to add an additional cohort to the ‘501’ trial in the third quarter to evaluate bioequivalence of IkT-001Pro relative to 600 mg imatinib mesylate with repeat dosing. 600 mg imatinib mesylate is commonly used to treat CML, but is poorly tolerated by up to 50% of patients. We believe IkT-001Pro may overcome the poor tolerability of high dose imatinib experienced by many patients, further differentiating the advantage of IkT-001Pro over current standard-of-care.”

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.