Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that it is advancing its Phase 2a study ('201 trial') following review of the study protocol and Phase 1/1b ('101 trial') data by the U.S. Food and Drug Administration (FDA or 'the Agency').
The 101 trial was a single and multiple ascending dose safety, tolerability and pharmacokinetics (PK) trial evaluating once daily administration of IkT-148009, the Company's lead c-Abl inhibitor for the treatment of Parkinson's disease. The study evaluated single doses up to 325 mg per day (the 'SAD study') and multiple doses up to 100 mg (the 'MAD study') in 88 older and elderly healthy adults and subsequently in 13 patients with mild to moderately advanced Parkinson's disease. Clinical pharmacology of IkT-148009 in patients closely paralleled the clinical pharmacology of IkT-148009 in older healthy volunteers. IkT-148009 also demonstrated a favorable safety and tolerability profile up to a dose of 325 mg with no clinically significant adverse events observed.
Following a review of IkT-148009 safety, tolerability and PK data in the first two cohorts of the 101 trial in Parkinson's patients at 50 and 100 mg as well as the 201 trial protocol, the FDA agreed with the Company's view that proceeding with the 201 trial was appropriate without restrictions. Based on this feedback, Inhibikase will continue to advance the 201 trial and end enrollment of the 101 trial.
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