FDA clears Inhibikase IkT-001 Phase II trial to treat JCV infection in multiple sclerosis patients

Inhibikase Therapeutics, Inc., an emerging leader in infectious disease, announced today that it has received FDA clearance to commence a Phase II proof-of-concept trial for its lead compound IkT-001.  IkT-001, a host-directed kinase inhibitor, is intended to clear JC polyomavirus (JCV) infection, the causative agent of Progressive Multifocal Leukoencephalopathy (PML).  This proof-of-concept trial will be conducted in multiple sclerosis (MS) patients on natalizumab (TYSABRI®), a patient group that is at significant risk for developing the potentially fatal PML disease.  JCV progresses to PML only in patients with chronic or drug-induced immune suppression, to include patients diagnosed with clinical AIDS or who are receiving monoclonal antibody treatment for MS, lupus, rheumatoid arthritis, leukemia or lymphoma.

The Phase II trial will be a four-week, open-label, sequential-dose-ranging study of the compound's safety and its antiviral effects against JCV in 48 patients with a relapsing form of MS who receive TYSABRI® infusion therapy.  In addition to closely monitoring the safety and pharmacokinetic profile of IkT-001, the study also will determine the potential antiviral effect of IkT-001 against JCV as measured by the suppression of urinary excretion of JCV.  Led by Jeffrey English, MD, of the Multiple Sclerosis Center of Atlanta, the study will be performed at three to five U.S. treatment centers for MS. All participating centers must be registered with the TOUCH Program for the prescription and infusion of TYSABRI® to patients with MS.

"The launch of this study is a pivotal event for Inhibikase Therapeutics, just 23 months into operations, as we advance a new approach to treating bacterial and viral infectious diseases into the clinic," said Milton H. Werner Ph.D., Chief Executive Officer and President of Inhibikase Therapeutics.  "If IkT-001 proves to be efficacious at suppressing JCV in MS patients on TYSABRI®, then a much broader population of patients at potential risk of contracting PML could benefit from this approach to preempting the virus from reaching the brain and causing the disease.  The common mechanism of action utilized by IkT-001 enables treatment for bacterial and viral infectious disease, thus an efficacious outcome for this Phase II study could clear a path for multiple indications using the same pharmaceutical approach."