Clinical stage biopharmaceutical company Cerevance has reportedly completed its Phase 1 clinical trial of CVN424, the company’s first-in-class, oral drug in development for treating Parkinson’s disease. The clinical study effectively attained its chief endpoint of safety in healthy volunteers.

The study reportedly comprised 64 healthy volunteers who were given either single dose or 7 daily doses of CVN424, extending from 1 mg to 225 mg, or placebo. There were no adverse events or clinically noteworthy changes in vital signs, laboratory values or ECG values. The drug was quickly absorbed orally and held a half-life that would support once-daily dosing, cited sources.

David H. Margolin, MD, Ph.D., Cerevance’s Senior VP for Clinical and Translational Medicine, said that CVN424’s brilliant safety profile helps authenticate the company’s approach to drug discovery and CNS target selection. The drug acts via a target that is selectively expressed by neurons significant in managing movement and was designed to attain excellent CNS penetration with nominal effects on other organs, Margolin added.

CVN424 targets novel, non-dopaminergic target protein, particularly existent in dopamine receptor D2-expressing medium spiny neurons within the basal ganglia’s indirect pathway. The drug controls the indirect pathway dependent on D2, but not the direct pathway dependent on D1. This selective aiming is developed to produce positive therapeutic effects of present treatments while preventing side effects like dyskinesia linked with dopaminergic therapies, cited sources familiar with the new therapy.

Brad Margus, CEO of Cerevance, said in a statement that the company is satisfied with the outcomes of the Phase 1 trial results for CVN424 and are keen on advancing to Phase 2. The company’s NETSseq technology platform makes use of human post-mortem brain tissue to detect targets that are selectively expressed in certain cell types and circuits or altered in disease states, enabling discovery of new treatments for neurodegenerative diseases, Margus added. 

On the basis of the positive Phase 1 outcomes, a Phase 2 study to exhibit the clinical advantages of CVN424 will be commenced later this year, reported sources.
Source Credits: https://www.businesswire.com/news/home/20190430005080/en/Cerevance-Achieves-Key-Endpoints-Phase-1-Clinical