Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
BOSTON and ATLANTA, March 8, 2023 /PRNewswire/ -- 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 ("FDA" or "Agency") has lifted the full Clinical Hold on IkT-148009, the Company's c-Abl inhibitor, in Multiple System Atrophy (MSA) allowing the Company to proceed with its plans for a future Phase 2 clinical trial in MSA.
- "We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in MSA," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics.
- One of two ongoing model studies has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009.
- With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population.
- Clinical effect on the progression of atrophy will be monitored in the trial using MRI.