Cerevance has dosed the first patient in its ASCEND Phase II study to assess the efficacy and safety of CVN424 as a monotherapy in early-stage Parkinson’s disease.
In February 2023 the company expanded its Series B funding round, raising a total of $116 million.
“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,” said Craig Thompson, Chief Executive Officer of Cerevance.
“This study aims to build upon the promising results from our previous Phase II 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.”
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.
In the study, 60 individuals aged 30 years and older will be randomised to receive a once daily dose of either CVN424 150mg 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.
Additionally, the study will employ several digital health technologies to provide objective measures of disease progression or lack of disease progression.
The findings of the study will assist in the design of the Phase III 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.