Inhibikase Therapeutics Granted Pre-NDA Meeting with the FDA for IkT-001Pro
BOSTON and ATLANTA, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration has granted a pre-New Drug Application (pre-NDA) meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting.
- The Company expects to provide an update following the meeting.
- “We are pleased that the FDA has granted a pre-NDA meeting to discuss the parameters for approval of IkT-001Pro,” stated Dr. Milton Werner, President and Chief Executive Officer of Inhibikase Therapeutics.
- Across all doses, there were only mild adverse events observed, including just two adverse events for IkT-001Pro at the highest dose comparison.
- Pharmacokinetic profiles for imatinib delivered by IkT-001Pro and imatinib mesylate were similar at equivalent doses.