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The randomized Phase 1 study investigated the safety, tolerability, and pharmacokinetics (PK) of IkT-148009 in healthy volunteers aged 45 to 70 years old.
Forty-two patients were dosed with IkT-148009 between 12.5 and 100 mg with no clinically significant adverse events reported.
High drug exposures were achieved in this dose range and were consistent with exposures observed in animal efficacy studies of inherited and sporadic progressive Parkinson's disease.
The extension of the Phase 1 study into the patient population, a Phase 1b, will focus on safety, tolerability, and pharmacokinetics measured over 7 to 14 days.
The Company is completing 13-week pivotal toxicology studies to be submitted to the FDA for review in August.
IkT-148009 is a selective c-Abl kinase inhibitor that inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family.
Price Action: IKT shares are down 2.05% at $2.38 during the market session on the last check Monday.
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