Inhibikase receives FDA guidance on 505(b)(2) path for IkT-001Pro; Parkinson's trial enrolling 51 patients

Inhibikase Therapeutics, Inc.

FDA pre-NDA meeting on Jan 19, 2024: acknowledges 505(b)(2) pathway appropriate for IkT-001Pro in blood/gastrointestinal cancers.
Bioequivalence shows 600mg/800mg IkT-001Pro similar to 400mg/600mg imatinib; FDA advises evaluating doses up to 800mg.
Company to seek all 11 imatinib indications; must conduct gut transporter studies and use-related risk analysis.
Risvodetinib 201 Trial: 32 sites open, 51 enrolled, 23 completed 12 weeks, 10 mild/moderate AEs reported.

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