Inhibikase Therapeutics, Inc. Receives FDA Clearance to Initiate Phase 2 Clinical Trials for Potential Disease-Modifying Therapies to Treat Parkinson’s Disease

Atlanta, GA and Cambridge, MA – (September 12, 2016) – Inhibikase Therapeutics, Inc., a developer of cellular Abelson tyrosine kinase inhibitors to treat infections and other diseases in the central nervous system, has received FDA clearance to initiate two Proof-of-Principle studies to apply its kinase inhibitor strategy as potential disease-modifying therapies for Parkinson’s Disease.

The Company has discovered and developed a series of novel Abelson tyrosine kinase inhibitors using its proprietary RAMP technology engine and validated their activity in pre-clinical animal models for multiple therapeutic indications in the brain.  These inhibitors are up to 60-times the potency of the prototypical Abelson tyrosine kinase inhibitor imatinib (marketed as Gleevec®).    Recently published studies suggested that drugs in this class could block a key checkpoint in the brain possibly linked to the progression of Parkinson’s Disease.   The Company’s orally delivered medications block this checkpoint in the brain in animal models of Parkinson’s Disease.  Two of these molecules are completing the necessary evaluations of toxicology and pharmacology in preparation for regulatory filings with the U.S. FDA in 1Q17.

To validate this approach in Parkinson’s patients, the Company filed Investigational New Drug (IND) applications to determine if the Abelson kinase inhibitors Tasigna® and Sprycel® can modify Parkinson’s Disease in patients.  In two simultaneous planned clinical trials, double-blinded, placebo-controlled clinical studies in Stage 2 and Stage 3 Parkinson’s patients will be conducted over a 6 month period.  These trials will evaluate the ability of these drugs to slow the progression of or even begin to reverse the course of Parkinson’s Disease in patients.

“We have watched for the past year as key opinion leaders in the Parkinson’s field evaluated Tasigna® in animal models and in patients with Parkinson’s Disease.  Recently published work suggested Tasigna® may have a clinical benefit, but without proper controls, it is unclear if the benefits observed are a true measure of clinical effect,” noted Inhibikase CEO Dr. Milton Werner.  “Since our novel, orally delivered Abelson kinase inhibitors are as much a 50-times more penetrant into the brain than Tasigna®, as we advance these novel drugs through the regulatory process, we want to simultaneously evaluate inhibitors in this drug class for clinical risk/benefit to better understand which patients with Parkinson’s Disease are more likely to benefit from this Abelson kinase inhibitor therapy. These studies will be undertaken at a single site in the United States and should begin patient evaluation for enrollment within a few months.”

About Inhibikase Therapeutics, Inc.

Inhibikase Therapeutics’ is a small molecule specialty pharmaceutical company that enables treatment of bacterial AND viral infectious disease through a common mechanism of action that is being extended into multiple therapeutic areas.  Founded in 2008 and headquartered in Atlanta, Georgia with offices in Cambridge, Massachusetts, Inhibikase Therapeutics is developing treatments for orphan indications involving viral infections in the brain and for neurodegenerative disease.

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