Risvodetinib (IkT-148009)
A Novel, Selective, Oral c-Abl Kinase Inhibitor
Risvodetinib (IkT-148009) is our lead product candidate to treat Parkinson’s and related diseases. Emerging from our RAMP™ discovery engine, Risvodetinib (IkT-148009) is currently completing Phase 2 studies in untreated Parkinson’s patients evaluating the safety, tolerability and efficacy of oral, once a day Risvodetinib (IkT-148009) therapy at three doses given for 12 weeks (the 201 Trial, www.201trial.com). Efficacy endpoints include assessing motor and non-motor function in the brain and gastrointestinal tract. In a Phase 1 clinical study of 88 older and elderly healthy volunteers, Risvodetinib (IkT-148009) displayed an excellent safety profile up to 325 mg given once daily or 25 mg daily for seven days with no clinically significant adverse events observed. In a Phase 1b clinical study ongoing, Risvodetinib (IkT-148009) displayed the same excellent safety profile as seen in healthy volunteers and similar drug pharmacology. Phase 1 and 1b trial results are published. See our Publications.
In validated animal models of progressive, alpha-synuclein-dependent disease, Risvodetinib (IkT-148009) that was given therapeutically halted disease progression and led to functional recovery in under eight weeks of oral treatment. Remarkably, Risvodetinib (IkT-148009) nearly cleared pathological alpha-synuclein from the affected neurons and the gastrointestinal tract in a manner that correlated with functional recovery. We believe this is the first time this has been observed for any oral therapy attempting to treat Parkinson’s disease in a living organism. The four major disease pillars of Parkinson’s are suppressed by Risvodetinib (IkT-148009) in multiple validated animal models include:
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IkT-001Pro
A Prodrug of the Anticancer Agent Imatinib Mesylate (marketed at Gleevec®)
IkT-001Pro is the first product candidate that deploys our prodrug technology. A prodrug is a precursor formulation of an active drug substance that enhances specific properties to improve drug delivery in patients. We have developed a platform prodrug technology that adds a small linker to a known or novel kinase inhibitor and suppresses on-dosing side effects common to drugs in this class, particularly gastrointestinal disturbance (nausea, diarrhea and/or vomiting).
