Inhibikase Therapeutics Reports Results from Phase 2 201 Trial for Risvodetinib

On January 29, 2025, Inhibikase Therapeutics, Inc. (NYSE:IKT) disclosed findings from the Phase 2 201 trial (the “201 Trial”) evaluating risvodetinib, a selective inhibitor of non-receptor Abelson Tyrosine Kinases, in untreated Parkinson’s disease.

The 201 Trial involved 126 individuals with untreated Parkinson’s disease who were, on average, 14 months post-diagnosis. Participants received doses of 50 mg, 100 mg, 200 mg, or placebo over 12 weeks. The principal objectives of the trial were to assess safety and tolerability, alongside 15 secondary endpoints to gauge treatment benefits.

Key findings from the trial include:
– Meeting the primary endpoint of safety and tolerability with 95% completion rate of the 12-week risvodetinib treatment.
– Observations of adverse events with risvodetinib were akin to placebo in terms of frequency and severity, with no severe treatment-related adverse events noted.
– No demonstrable improvement in the top hierarchical efficacy measure, the sum of Parts 2 and 3 of the Movement Disorder Society Universal Parkinson’s Disease Rating Scale (MDS-UPDRS), with risvodetinib treatment across the dosage groups (50mg, 100mg, or 200mg) compared to placebo.
– Improvement at 100 mg in Part 2 of the MDS-UPDRS and at 50 mg in the Schwab & England Activities of Daily Life Scale.
– Encouraging signs in alpha-synuclein pathology analysis utilizing skin biopsy, indicating a dose-dependent reduction in neuronal alpha-synuclein deposition in cutaneous nerve fibers across all dosages.

Furthermore, Inhibikase Therapeutics will halt further development of risvodetinib to focus on advancing the lead program, IkT-001Pro, in pulmonary arterial hypertension (“PAH”). The company will contemplate strategic options for the risvodetinib program.

The disclosure includes forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, highlighting the Company’s intentions, beliefs, and strategies. These statements are based on current estimates and assumptions and involve risks and uncertainties that could affect actual outcomes and results. Factors such as the ability to commence and execute a Phase 2b ‘702’ trial for evaluating IkT-001Pro pose potential challenges.

The Company emphasized the importance of evaluating the risks noted in its regulatory filings. The statements made in the report are as of the publication date, and the Company does not commit to updating them post-publication, except when required by law.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Inhibikase Therapeutics’s 8K filing here.

About Inhibikase Therapeutics

Inhibikase Therapeutics, Inc, a clinical-stage pharmaceutical company, develops therapeutics for Parkinson’s disease and related disorders. Its lead product candidate is IkT-148009, a non-receptor Abelson tyrosine kinase inhibitor, which is in Phase 2a clinical trials to the treatment of Parkinson’s disease and gastrointestinal tract.