Phase 2 trial of risvodetinib for Parkinson’s now fully enrolled
Patient enrollment is now complete in a Phase 2 trial that’s assessing the safety and efficacy of oral risvodetinib, being developed by Inhibikase Therapeutics to slow or stop the progression of Parkinson’s disease.
The 201 trial (NCT05424276) has enrolled 120 participants across 32 sites in the U.S., and expects to involve 126 patients, this way not to exclude already screened participants from the trial. To date, 69 patients have completed dosing, with a total of 32 mild and five moderate adverse events potentially related to the treatment reported.
Previously reported data from 25 patients who completed dosing demonstrated that risvodetinib appeared to stabilize disease progression and symptom severity. Inhibikase expects to report top-line data later this year, according to a company press release.
“The completion of enrollment for the 201 Trial in untreated Parkinson’s disease represents a major milestone for Inhibikase,” said Milton H. Werner, PhD, Inhibikase’s president and CEO. “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.”
Risvodetinib, previously known as IkT-148009, is an oral small molecule that blocks the activation of Abelson tyrosine kinase, an enzyme involved in multiple cellular processes and a known target for the treatment of Parkinson’s.
By blocking this enzyme, risvodetinib helps restore protective mechanisms in the brain and gastrointestinal tract, which is expected to prevent the loss of dopaminergic neurons — dopamine-producing nerve cells — and to slow or stop Parkinson’s progression. Dopamine is a neurotransmitter that plays a role in many bodily functions, including movement, memory, and mood.
Eligible patients for the study included those who had never received and were not planning to start treatments to control Parkinson’s symptoms, but who displayed bradykinesia, or slowness of movements, an early sign of the disease.
June 21, 2024
