Inhibikase Therapeutics granted pre-NDA meeting with FDA for IkT-001Pro

Inhibikase Therapeutics announced the U.S. Food and Drug Administration has granted a pre-New Drug Application meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting. 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. The study also evaluated an additional cohort of 8 healthy subjects to determine the bioequivalent dose of IkT-001Pro to 600 mg imatinib mesylate, a dose that is poorly tolerated in patients. This additional cohort identified 900 mg of IkT-001Pro as bioequivalent. Across all doses, there were only mild adverse events observed, including just two adverse events for IkT-001Pro at the highest dose comparison. Imatinib delivered by IkT-001Pro demonstrated a slower rise time to maximum plasma concentration of 6 hours, compared to the 4-hour Tmax of 400 mg imatinib mesylate. Pharmacokinetic profiles for imatinib delivered by IkT-001Pro and imatinib mesylate were similar at equivalent doses. Imatinib mesylate is currently approved for treatment of Philadelphia chromosome positive chronic myelogenous leukemia and acute lymphoblastic leukemia, adults with myelodysplastic or myeloproliferative disease associated with mutations in the PDGFR genes, mastocytosis associated with mutations in the c-Kit gene and stomach cancers that arise from mutations in the c-Kit or PDGFR genes.