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Inhibikase To Start Testing Its Parkinson's Candidate In Patients

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  • The FDA has signed off Inhibikase Therapeutics Inc's (NASDAQ: IKT) Phase 1b extension study to evaluate its lead drug candidate IkT-148009 in Parkinson's patients.

  • 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.

  • Related content: Benzinga's Full FDA Calendar.

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