Boston, MA – November 13, 2023 – Cerevance, a company focused on developing novel precision therapeutics for central nervous system (CNS) diseases, today announced that the first subject has been dosed in the Phase 2 clinical study of CVN424 in individuals with early-stage Parkinson’s disease. The ASCEND (A novel Selective Compound to ENable Individuals with Parkinson’s Disease) study will explore the potential use of CVN424 as a novel and innovative treatment option for individuals with early-stage Parkinson’s disease.
"We are delighted to announce the commencement of our ASCEND study in individuals who have recently been diagnosed with Parkinson's disease and not yet received levodopa treatment," stated Craig Thompson, chief executive officer of Cerevance. "This study aims to build upon the promising results from our previous Phase 2 trial of CVN424 as an adjunctive therapy for later-stage Parkinson's disease. Our objective is to demonstrate the advantages of CVN424 over existing treatments in improving both the motor and non-motor symptoms of Parkinson's disease. With ASCEND, we take a significant step closer to providing patients with an innovative, safe, and well-tolerated treatment that addresses multiple facets of this disease."
The Phase 2 ASCEND study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of CVN424 in individuals with early, untreated Parkinson’s disease. Sixty individuals aged 30 years and older will be randomized to receive a once daily dose of either CVN424 150 mg or placebo. The primary endpoint of the study is CVN424’s ability to improve Parkinson’s disease motor symptoms and the impact of those symptoms on activities of daily living, as measured by Parts II and III of the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) after 12 weeks of administration. Additionally, the study will employ several digital health technologies to provide objective measures of disease progression or lack of disease progression. The findings of this study will assist in the design of the Phase 3 study for the treatment of Parkinson’s disease in individuals with early-stage disease and potentially, to test the ability of CVN424 to delay disease progression and thereby delay the initiation of treatment with levodopa.
For additional study information, please visit https://www.clinicaltrials.gov/study/NCT06006247?term=cvn424&rank=2 and https://ascendclinicaltrial.com
CVN424 is a first-in-class non-dopamine therapy that selectively modulates GPR6, an orphan G-protein coupled receptor. Expression of GPR6 is largely confined to the subset of striatal projection neurons that give rise to the indirect (striatopallidal) pathway, important in the control of movement. CVN424 shows promise in improving both the motor (significant reduction of 1.5 hours in OFF time versus placebo) and non-motor symptoms of Parkinson's disease. Further, CVN424 has shown to be safe and well tolerated without dopaminergic side effects and may also have disease-delaying effects.
Cerevance is focused on the development of precision treatments for central nervous system (CNS) disorders, prioritizing chronic neurodegenerative conditions such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS). Utilizing a large and growing collection of over 14,000 human brain tissue samples, Cerevance is generating an unprecedented level of expression and epigenetic data thereby enabling the company to identify the most promising targets for the next generation of treatments for CNS disorders.
The company utilizes its proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform and advanced machine learning techniques to uncover the gene expression profiles of select cell types to identify novel targets that are uniquely expressed in relevant circuits affected by diseases or are altered in disease states. With the information obtained from its research, combined with the expertise of its team of scientists and drug developers, Cerevance is advancing multiple therapeutics that selectively modulate the discovered targets. These treatments are progressing through clinical development, with CVN424, CVN766, and CVN293 being the furthest along in the pipeline. CVN424 is a first-in-class non-dopamine therapy that shows promise in improving both motor and non-motor symptoms of Parkinson's disease and may also have disease-delaying effects. CVN766 is a potent antagonist of the orexin 1 receptor with high selectivity over the orexin 2 receptor which may benefit a variety of psychiatric conditions including schizophrenia, anxiety/panic, binge eating/obesity, substance use disorder, and Prader-Willi Syndrome. CVN293 is a novel blocker of potassium efflux in glia, regulating the inflammasome in individuals living with ALS and Alzheimer's disease.
By leveraging its extensive collection of brain tissue samples, employing advanced technologies, and generating actionable data, Cerevance aims to transform the lives of patients affected by CNS diseases.
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