Inhibikase Therapeutics Completes Phase 2 Enrollment for Risvodetinib in Parkinson’s Disease

Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical firm focused on developing protein kinase inhibitor treatments for Parkinson's disease and related conditions, announced the completion of participant enrollment for its Phase 2 '201' trial. This trial is designed to evaluate the safety and tolerability of risvodetinib (“risvo”), a selective c-Abl inhibitor, in patients with untreated Parkinson’s disease. Results from the trial are anticipated in the fourth quarter of 2024.

Dr. Milton H. Werner, the President and CEO of Inhibikase, emphasized that reaching this enrollment milestone underscores the diligent efforts of the Inhibikase team and the efficiency of their innovative patient identification and referral services. Furthermore, he acknowledged the dedication of the 32 U.S. study sites involved in the trial. With enrollment finalized, the company is now preparing for discussions with the FDA regarding pivotal Phase 3 trials by the end of the year.

The '201' trial is a 12-week, randomized, double-blind, multi-center, placebo-controlled study aimed at assessing three different doses of risvodetinib in untreated Parkinson’s patients. The trial has successfully enrolled 120 participants across 32 sites within the United States. An additional six participants will be included to ensure that already screened individuals can continue to participate, bringing the total to 126. As of June 17, 2024, 69 participants have completed the 12-week dosing period. The trial has reported 32 mild and 5 moderate adverse events potentially related to risvodetinib, and four participants have withdrawn from the study before completing the 12-week treatment period.

Inhibikase Therapeutics, headquartered in Atlanta, Georgia, with offices in Lexington, Massachusetts, is advancing a multi-therapeutic pipeline primarily focused on neurodegeneration. The company's leading program, risvodetinib, targets Parkinson's disease both within and outside the brain, as well as other conditions associated with Abelson Tyrosine Kinases. Their pipeline also addresses Parkinson's-related disorders affecting the brain and gastrointestinal tract, orphan indications such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors like IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, which is expected to enhance patient experience by reducing on-dosing side effects.

Inhibikase's RAMP™ medicinal chemistry program has identified several follow-on compounds to risvodetinib, with potential applications in other cognitive and motor function disorders of the brain. The company’s efforts reflect a broad and ambitious strategy to modify the course of neurodegenerative diseases, offering hope for improved treatment options for patients suffering from these debilitating conditions.

The forthcoming results from the Phase 2 '201' trial are eagerly anticipated, as they will provide crucial data on the efficacy and safety of risvodetinib in treating untreated Parkinson’s disease. These results will also guide the company’s discussions with the FDA and shape the design and implementation of future pivotal Phase 3 trials.