At Inhibikase, we developed IkT-001Pro as an outgrowth of our efforts to improve the safety of the first FDA-approved Abl kinase inhibitor, imatinib (marketed as Gleevec®), which is commonly taken for hematological cancers that arise from Abl kinase mutations in the bone marrow or for gastrointestinal cancers that arise from c-Kit mutations in the stomach.
IkT-001Pro has shown to be potentially as much as five times safer than imatinib in non-human primates, blunting the severe gastrointestinal side effects of imatinib therapy that occur following 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 patients' quality of life while on therapy.
IkT-001Pro has received Orphan Drug Designation for stable-phase CML and will follow the development pathway for approval through the 505(b)(2) regulation.
This pathway would allow us to rely, in part, on data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of an approved compound.
