Jason Mccarthy's questions to Inhibikase Therapeutics Inc (IKT) leadership • Q2 2024
Question
Jason Mccarthy of Maxim Group inquired about the risvodetinib Phase II study, specifically asking about the potential lag time for patients moving to the 12-month open-label extension (OLE) and the risk of them starting symptomatic treatments. He also sought details on the planned Phase III program, including whether it would entail two studies and its duration. Finally, he asked for specifics on the size and scope of the Phase IIb trial for IkT-001Pro in pulmonary arterial hypertension (PAH).
Answer
Executive Milton Werner confirmed a lag has occurred with the OLE due to financial constraints but expects a formal launch within a couple of months, noting that few patients have started symptomatic meds so far. For Phase III, he stated the plan is for two global trials, dosing for up to 12 months, with a combined enrollment of 300-400 patients. For the PAH Phase IIb study, Werner described a derisking trial of roughly 100 patients across two doses plus placebo, with a 24-week measurement duration, designed to confirm efficacy and improve upon the safety profile of imatinib.