Inhibikase stock rises 12% on FDA nod to start study of IkT-001Pro for leukemia

Aug. 26, 2022 8:36 AM ETInhibikase Therapeutics, Inc. (IKT)By: Ravikash, SA News Editor

Headquarters of US Food and Drug Administration (FDA)


  • The U.S. Food and Drug Administration (FDA) cleared Inhibikase Therapeutics (IKT) application seeking to start a trial of IkT-001Pro to treat Chronic Myelogenous Leukemia (CML).
  • The company said IkT-001Pro will be evaluated in a bioequivalence study, which will enroll ~64 healthy people aged 25 to 55 who will receive IkT-001Pro at one of four doses.
  • Inhibikase noted that 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).
  • "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," said President and CEO Milton Werner.
  • IKT +11.77% to $0.98 premarket Aug. 26

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