Enrollment now complete for Phase 2 PROSEEK study of vodobatinib
Trial is testing safety, efficacy of oral therapy across 84 sites
Enrollment is now complete for a Phase 2 trial that’s assessing the safety and efficacy of oral vodobatinib (K0706), an experimental Abl inhibitor, in people with early Parkinson’s disease across 84 clinical sites in the U.S., Europe, and India.
The placebo-controlled trial (NCT03655236), dubbed PROSEEK and sponsored by Sun Pharma Advanced Research Company (SPARC), enrolled 506 patients, ages 50 or older.
Participants were diagnosed with “Clinically Probable Parkinson’s,” according to clinical diagnostic criteria, with symptoms arising within three years before trial screening. They were not expected to have to start treatment with dopamine-replacing therapies within nine months of entering the study.
“This is a significant milestone for SPARC & Vodobatinib. I would like to express my gratitude to all the patients, caregivers and the physicians associated with PROSEEK,” Anil Raghavan, CEO of SPARC, said in a company press release.
Trial is testing effect of vodobatinib on patients’ motor function
Vodobatinib, also known as SCC-138, is a first-in-class, brain-penetrant inhibitor of an enzyme called Abl tyrosine kinase. Its activity is important for processes associated with Parkinson’s, such as oxidative stress and alpha-synuclein-induced neurodegeneration.
Oxidative stress is a type of cellular damage resulting from an imbalance between the production of potentially harmful oxidant molecules and the cells’ ability to eliminate them with antioxidants. The accumulation of toxic clumps of the alpha-synuclein protein, which lead to the death of dopamine-producing neurons, is a hallmark of Parkinson’s.
According to SPARC, “PROSEEK is one of the largest Phase 2 [studies] in patients with early Parkinson’s disease.”
Study sites can be found in more than 20 U.S. states, plus the District of Columbia. The trial launched in 2019 and is expected to run through 2024.
The double-blind trial consists of two parts. In the first part, participants are randomly assigned to receive one of two doses of vodobatinib or a placebo, taken daily for 40 weeks, or about nine months. Neither researchers nor participants know which patients are given vodobatinib and which the placebo.
Part two is a long-term extension phase open to patients who complete the trial’s first part.
The study’s main goal is to assess changes in patients’ motor function at the end of the study, using the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 3.
Additional assessments of patients’ motor function, time to initiate medication, changes in disease severity, and impact on health-related quality of life also will be evaluated as secondary goals.
As an exploratory goal, researchers will assess vodobatinib’s impact on the health of dopamine-producing neurons in Parkinson’s patients using Dopamine Transporter Single Photon Emission Computed Tomography (DaT SPECT) brain imaging.
DaT SPECT is an imaging tool that can be used to distinguish people with Parkinson’s from healthy people, even in early stages of the disease. It does so by tagging dopamine transporters in the outer membrane of dopamine-producing neurons, a hallmark feature of healthy cells.
If positive, results from this trial are expected to support the advancement of vodobatinib into Phase 3 clinical studies in Parkinson’s patients.
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