Inhibikase Therapeutics Completes Enrollment of the Phase 2 ‘201’ Trial Evaluating Risvodetinib in Untreated Parkinson’s Disease

By: Inhibikase Therapeutics via GlobeNewswire

June 17, 2024 at 08:05 AM EDT

BOSTON and ATLANTA, June 17, 2024 (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 company has completed enrollment in the Phase 2 ‘201’ trial evaluating the safety and tolerability of risvodetinib (“risvo”), a potent selective c-Abl inhibitor, for treatment in untreated Parkinson’s patients. The company expects to report trial results in the fourth quarter of 2024.

"The completion of enrollment for the 201 Trial in untreated Parkinson’s disease represents a major milestone for Inhibikase,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “This achievement reflects the hard work of our team, the success of our proprietary and innovative patient identification and referral service and the commitment of our 32 U.S. study sites to evaluating potential disease-modifying solutions for patients with this debilitating disease. With enrollment in the study now complete, we look forward to reporting trial results in the fourth quarter, and the discussion with the FDA on our plans for pivotal Phase 3 trials by the end of the year.”

The 201 Trial is a 12-week, randomized, double-blind, multi-center, placebo-controlled clinical trial evaluating three risvo doses in patients with untreated Parkinson’s disease to assess safety, tolerability and efficacy of risvo in untreated Parkinson’s disease. The trial has enrolled all 120 participants across 32 sites across the United States, and expects to randomize 126 patients total so as not to exclude already screened participants from participating in the trial. As of June 17, 2024, 69 participants have completed the 12-week dosing period. To-date, there have been 32 mild and 5 moderate adverse events observed that may be related to risvo treatment. Four people withdrew from the trial without completing 12 weeks of treatment.

About Inhibikase (www.inhibikase.com)

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 risvodetinib, 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 several follow-on compounds to risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts.

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Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete the 201 Trial evaluating risvodetinib in untreated Parkinson’s disease, to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications, to successfully conduct clinical trials that are statistically significant and whether results from our animal studies may be replicated in humans, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:

Company Contact:
Milton H. Werner, PhD
President & CEO
678-392-3419
info@inhibikase.com

Investor Relations:
Alex Lobo
Stern Investor Relations, Inc.
alex.lobo@sternir.com