Inhibikase Therapeutics provides update on Parkinson’s trials

Inhibikase Therapeutics reported updates in the design and execution of its Phase 2 ‘201’ program with IkT-148009 to treat Parkinson’s disease. "We continue to make progress in our ‘201’ program in Parkinson’s disease following the clinical hold lift by the FDA earlier this year," remarked CEO Milton Werner. "We have worked diligently to implement protocol changes arising from our agreements with the FDA and now have multiple sites screening patients. In addition, we have implemented newly described biomarker analyses in the skin and spinal fluid into the trial to analyze the response to treatment for enrolled patients.1-2 In parallel, we have completed the evaluation of safety and steady-state pharmacokinetics of the 200 mg dose of IkT-148009 in healthy volunteers. These data have been submitted to the FDA and support the inclusion of the 200mg dose in the ‘201’ trial. We look forward to enrolling the multiple patients in Q2 and will provide additional updates as enrollment progresses." Site activation for the ‘201’ is trial ongoing. It is anticipated that 30 sites will be screening patients by the end of Q2. Analysis of Phase 1b data at 50 mg and 100 mg doses provided further encouragement that these doses should be studied in the 201 trial. MDS-UPDRS Part I declined for the 50 mg and 100 mg dose groups by an average of -4.33 and -1.8 points, respectively, while mean changes in Part II declined -2.0 and -1.4 points, respectively. Data support the inclusion of the 200mg dose in the ‘201’ trial and the company has submitted the data to the FDA.