Cerevance Reports Positive Phase 2 Results for Novel Parkinson's Drug Solengepras Targeting Motor Fluctuations and Sleep Symptoms
核心洞察
Cerevance (搜索)'s solengepras, a once-daily oral GPR6 (搜索) inhibitor, demonstrated significant reduction in OFF time frequency and duration in Parkinson's patients with motor fluctuations during Phase 2 adjunctive trials.
The ASCEND Phase 2 monotherapy trial showed potential benefits in non-motor symptoms versus placebo, with the largest standardized improvement observed in sleep-related symptoms.
The company will present these Phase 2 trial results at the AD/PD 2026 International Conference, highlighting the drug's novel non-dopaminergic approach to treating both motor and non-motor Parkinson's symptoms.
Cerevance (搜索) announced positive Phase 2 trial results for solengepras (CVN424), a novel once-daily oral GPR6 (搜索) inhibitor, showing significant improvements in motor fluctuations and sleep-related symptoms in Parkinson's disease (搜索) patients. The company will present these findings at the AD/PD 2026 International Conference on Alzheimer's & Parkinson's Diseases in Copenhagen from March 17-21.
Phase 2 Adjunctive Trial Shows Reduction in OFF Time
Post hoc analyses of Phase 2 adjunctive trial data demonstrated that solengepras significantly reduced the frequency and duration of OFF time in individuals with Parkinson's disease (搜索) experiencing motor fluctuations. These improvements largely translated into increased good ON time for patients, addressing a critical unmet need in Parkinson's management.
Karl Kieburtz, M.D., M.P.H., Co-founder of Clintrex Research LLC and Professor of Neurology at the University of Rochester, will present the OFF-time improvement characteristics on Saturday, March 21, 2026, at 12:10 p.m. CET.
ASCEND Monotherapy Trial Demonstrates Non-Motor Benefits
The Phase 2 ASCEND monotherapy trial revealed potential benefits in non-motor symptoms versus placebo, with the largest standardized improvement observed in sleep-related symptoms. This finding is particularly significant given that sleep disturbances represent a major quality-of-life issue for Parkinson's patients.
Aaron L. Ellenbogen, D.O., M.P.H., Medical Director at Quest Research Institute and Neurologist at the Parkinson's Disease (搜索) and Movement Disorders Center at Michigan Institute for Neurological Disorders, will present these sleep-related outcomes on Saturday, March 21, 2026, at 3:10 p.m. CET.
Novel Non-Dopaminergic Mechanism of Action
Solengepras represents a potentially groundbreaking approach to Parkinson's treatment through its unique mechanism of action. Unlike dopaminergic therapies that primarily act by replenishing, enhancing, or mimicking dopamine, solengepras selectively addresses the indirect pathway by modulating the GPR6 (搜索) receptor. By inhibiting GPR6, the drug aims to restore both motor and non-motor function without directly affecting dopamine levels or signaling, improving the relative balance between the direct and indirect pathways.
This non-dopaminergic approach potentially reduces the risk of common side effects associated with dopaminergic therapies, such as dyskinesias and motor fluctuations, which represent significant limitations of current standard treatments.
Phase 3 ARISE Trial Underway
Solengepras is currently being evaluated in the pivotal Phase 3 ARISE trial, a multicenter, randomized, double-blind, placebo-controlled study assessing its efficacy and safety as an adjunctive therapy to levodopa and other background Parkinson's disease (搜索) medications. The trial is enrolling approximately 330 patients with Parkinson's disease age 30 and older with motor fluctuations who have an average of three or more hours of total OFF time per day.
Study participants are randomized to receive solengepras 75 mg or 150 mg or placebo once daily for 12 weeks. The primary endpoint is the change from baseline to week 12 in average daily OFF time for solengepras 150 mg versus placebo. Secondary objectives include assessing safety and tolerability and further characterizing the effect of solengepras on other motor symptoms, non-motor symptoms including daytime sleepiness, cognitive function, and several quality-of-life measures.
Addressing Growing Global Disease Burden
Parkinson's disease (搜索) represents the fastest growing neurological disorder globally, affecting more than 10 million people worldwide and approximately 1 million people in the United States. The progressive neurodegenerative disorder is characterized by both motor symptoms, such as tremor, rigidity, and bradykinesia/akinesia, and non-motor symptoms, such as mood changes, apathy, and cognitive deficits.
The current standard of care has primarily relied on dopaminergic therapies, such as levodopa, which lose effectiveness over time and are associated with side effects that result in challenging risk-benefit profiles. This creates a significant unmet medical need for novel therapeutic approaches like solengepras.