Cerevance has commenced its Phase 3 ARISE clinical trial, evaluating solengepras as an adjunctive treatment for Parkinson's disease. The first patient has been dosed in this pivotal study, which aims to assess the efficacy and safety of solengepras in individuals already receiving levodopa and other Parkinson's medications. This trial marks a significant step forward in the development of a potentially first-in-class, oral, non-dopaminergic therapy for Parkinson’s.
Novel Approach to Parkinson's Treatment
Solengepras (CVN424) represents a novel approach to Parkinson's disease treatment by selectively modulating the GPR6 receptor in the indirect pathway, without directly affecting dopamine levels. This mechanism is designed to improve motor and non-motor functions, potentially reducing the risk of dyskinesias and motor fluctuations associated with traditional dopaminergic therapies.
"Parkinson’s disease is the fastest growing neurological disorder globally, highlighting a significant need for more improved and effective therapies," said Craig Thompson, chief executive officer of Cerevance. "Unlike traditional Parkinson’s treatments that aim to restore dopamine levels, solengepras is designed to selectively target and modulate the specific brain circuits responsible for controlling movement and non-motor functions, without relying directly on dopamine pathways."
ARISE Trial Design and Endpoints
The ARISE trial is a global, randomized, double-blind, placebo-controlled study planning to enroll approximately 330 patients experiencing three or more hours of "OFF" time per day. The primary endpoint is the change from baseline in total daily "OFF" time at Week 12. Secondary endpoints include changes in "ON" time without troublesome dyskinesia, motor function, quality of life (assessed by MDS-UPDRS), sleep quality (assessed by ESS), and cognitive and motor/non-motor impairment (evaluated using digital technologies like the Cogstate PD Battery and the Modality System).
Addressing Unmet Needs in Parkinson's Disease
Parkinson's disease affects over ten million people worldwide and approximately one million in the United States, and is characterized by motor symptoms like tremor, rigidity, and bradykinesia, as well as non-motor symptoms such as mood changes and cognitive deficits. Current treatments primarily rely on dopaminergic therapies, which can lose effectiveness over time and cause challenging side effects. Solengepras offers a potential alternative by targeting the GPR6 receptor to restore motor and non-motor function without directly affecting dopamine levels.
Anticipated Results
Cerevance expects to report topline data from the ARISE trial in the first half of 2026. The successful completion of this trial could pave the way for a new, non-dopaminergic treatment option for individuals with Parkinson's disease.
