Improved, Safer Imatinib
Inhibikase developed IkT-001Pro as an outgrowth of our efforts to improve the safety of the first FDA-approved Abl kinase inhibitor, imatinib (Gleevec®), which is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations in bone marrow or Kit kinase mutations in the stomach.
IkT-001Pro has been shown to be potentially as much as 13 times safer than imatinib in non-human primates, blunting the severe gastrointestinal side effects of imatinib therapy that occur on oral administration. Removing these gastrointestinal side effects has the potential to significantly improve the number of patients that reach and sustain complete cytogenetic response in stable-phase chronic myelogenous leukemia (CML). We believe that removing these side effects will also improve patient adherence to daily therapy and improve the quality of life of patients while on therapy.
IkT-001Pro for CML, which is on an accelerated development pathway for approval through the 505(b)(2) approval guidelines, may receive Orphan Drug Designation for stable-phase CML patients and may require only limited clinical evaluation for USFDA approval, subject to future USFDA agreements.