- Solengepras is a potentially first-in-class, oral, non-dopaminergic investigational therapy in development for Parkinson’s disease
- ARISE will evaluate the efficacy of solengepras as an adjunctive therapy to levodopa and other background Parkinson’s disease medications
- Company expects to report topline data in the first half of 2026
Boston, MA – November 18, 2024 – Cerevance, a clinical-stage biopharmaceutical company advancing multiple cell type-specific therapies for the treatment of neurodegenerative, psychiatric, and central nervous system-controlled metabolic disorders, has dosed the first patient in ARISE, a Phase 3 clinical trial evaluating the efficacy of solengepras as a potential adjunctive treatment for individuals with Parkinson’s disease.
“Parkinson’s disease is the fastest growing neurological disorder globally, highlighting a significant need for more improved and effective therapies,” shared 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. This novel mechanism of action is designed to reduce motor complications such as dyskinesia and “OFF” periods, which we believe may offer potentially improved tolerability and potential impact on non-motor symptoms for individuals with Parkinson’s disease.”
ARISE is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial, with a plan to enroll approximately 330 patients with three or more hours of “OFF” time per day. The primary endpoint is the change from baseline in the total daily “OFF” time at Week 12. Secondary endpoints include the change in “ON” time without troublesome dyskinesia, evaluations of motor function and quality of life, as assessed by the Movement Disorder Society-Unified Parkinson’s disease Rating Scale (MDS-UPDRS), the Epworth Sleepiness Scale (ESS), and the use of digital technologies, such as the Cogstate PD Battery (for the evaluation of cognition) and the Modality System (for the evaluation of motor/non-motor impairment). The trial will also evaluate the safety and tolerability of solengepras.
“The initiation of ARISE builds on the encouraging Phase 2 data we have generated and represents an exciting chapter in Cerevance’s journey to address the unmet needs of individuals with Parkinson’s disease,” added Sagar Vaidya, M.D., Ph.D., chief medical officer of Cerevance. “We look forward to advancing solengepras through this pivotal trial and moving closer to potentially bringing a new, non-dopaminergic therapy to the Parkinson’s community.”
For more information on the trial, please visit https://arise.clinicalenrollment.com or clinicaltrials.gov (NCT06553027).
About Solengepras (CVN424)
Solengepras is designed to provide a potentially novel approach to the treatment of Parkinson’s disease. Unlike dopaminergic therapies, which primarily act by replenishing, enhancing, or mimicking dopamine, solengepras is designed to selectively address the indirect pathway by modulating the GPR6 receptor. By inhibiting GPR6, solengepras 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, and potentially reducing the risk of common side effects associated with dopaminergic therapies, such as dyskinesias and motor fluctuations. Solengepras is currently being evaluated as a once-daily, oral treatment for use as both a monotherapy (Phase 2 ASCEND clinical trial) and as an adjunctive therapy to levodopa and other anti-Parkinsonian medication (Phase 3 ARISE clinical trial).
About Parkinson’s Disease
Parkinson’s disease is a progressive neurodegenerative disorder that 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. Globally, Parkinson’s disease is the fastest growing neurological disorders, affecting more than ten million people worldwide and approximately one million people in the United States. The current standard of care has primarily relied on dopaminergic therapies, which lose effectiveness over time and are associated with side effects that result in challenging risk-benefit profiles.
About Cerevance
Cerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative, psychiatric and central nervous system (“CNS”)-controlled metabolic disorders. Our proprietary platform, Nuclear Enriched Transcript Sort sequencing (NETSseq), allows us to identify targets that are expressed at very low levels, that are present in rare cell types, or that change over time as a disease progresses. Our most advanced product candidate, solengepras (CVN424), is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both the motor and non-motor symptoms of Parkinson's disease. Our second product candidate, CVN766, is designed to be a highly selective oral antagonist of the orexin 1 receptor that we plan to evaluate in a Phase 2 study for the potential treatment of binge eating disorder and schizophrenia. Our third product candidate, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13) and represents a potentially novel intervention point for neurodegenerative disorders by reducing neuroinflammation. We plan to evaluate CVN293 in a Phase 2 study for the potential treatment of frontotemporal dementia.
Contacts
Cerevance:
Johnna Simoes, ir@cerevance.com
Media
Andrew Mielach, amielach@lifescicomms.com, +1-646-876-5868
