Inhibikase Therapeutics (IKT) Announces FDA Clinical Hold on IkT-148009 Programs

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 that the Company was informed via e-mail communication that the U.S. Food and Drug Administration (FDA) has reviewed its Investigational New Drug (IND) application for IkT-148009 for the treatment of Multiple Systems Atrophy (MSA) and has issued a Clinical Hold on the IkT-148009 201 program in Parkinson's disease (PD) and the use of IkT-148009 in MSA. The FDA indicated it will provide an official clinical hold letter to Inhibikase within 30 days.

"We have not seen any serious adverse events in the ongoing 201 trial and we remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases," commented Milton H. Werner, Ph.D., President and Chief Executive Officer. "Given the safety, tolerability and pharmacokinetics data observed in clinical trials with IkT-148009 to date, we are actively working with the FDA to understand the agency's concerns and to resolve them as soon as possible."

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be potentially applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts.

Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD.

You May Also Be Interested In

• Ocugen doses first patient in Phase 3 gene therapy trial for dry AMD
• Enovis to acquire eCential Robotics for up to €211M
• Enovis agrees to acquire eCential Robotics for up to €211M