The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics’ (NASDAQ:IKT) Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro in the treatment of Chronic Myelogenous Leukemia (CML).
IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and enrolling approximately 64 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses.
The company anticipates initiating a bioequivalence study in the second half of 2022.
The study is designed to evaluate the safety profile of IkT-001Pro as well as identify a dose with a similar systemic exposure and pharmacokinetic profile compared to 400 mg imatinib mesylate at 96 hours post administration.
Milton H. Werner, President and Chief Executive Officer, commented: “We are excited to have received the SMP letter from the FDA for IkT-001Pro for CML. This represents the first program to emerge from our novel prodrug platform, which aims to improve the safety and tolerability of approved and novel therapeutics. Based on preclinical studies, we believe that IkT-001Pro has the potential to significantly improve the safety profile of oral imatinib, which may enhance patient adherence and quality of life, potentially leading to better rates of complete cytogenetic response.”
Chronic myeloid leukemia (CML) is a slowly progressing cancer that affects the blood and bone marrow.
Price Action : Inhibikase shares are trading around 20 percent higher at $1.05 on Friday during pre-market session.
