Inhibikase Therapeutics, Inc. announced the completion of its bioequivalence study of IkT-001Pro compared to 400 mg imatinib mesylate. The '501' bioequivalence study evaluated IkT-001Pro at four single ascending doses of 300, 400, 500 and 600 mg in 27 healthy subjects ranging in age from 18 to 55, followed by a pivotal phase comparing the 600 mg of IkT-001Pro to 400 mg imatinib Mesylate in 31 healthy volunteers. In total, fifty adverse events were observed following treatment with IkT-001Pro or commercial 400 mg imatinib mesyate, 24 of which were possibly or probably related to the administration of either study drug to the participants in the trial.

Imatinib delivered by IkT-001Pro demonstrated a slower rise time to maximum plasma concentration (Tmax) of 6 hours, compared to the 4-hour Tmax of 400 mg imatinib mesyrate, but displayed lower inter-patient variability relative to standard-of-care. Mean and median maximum plasma concentration (Cmax) and overall exposure (AUC0-infinity) were approximately 16% higher for IkT-001Pro relative to 400 mg imatinibmesylate, consistent with higher total imatinib delivery by 600 mg IkT-001Pro. About IkT-001Pro: 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 arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Ableson Kinases. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from these in the future.