Cerevance, a clinical stage biopharmaceutical company advancing new medicines for brain diseases, announced today the initiation of a Phase 2 clinical trial of CVN424, an oral, first-in-class compound that selectively modulates a novel, non-dopaminergic target selectively expressed in an important class of neurons in the striatum.
“We are pleased to further advance the clinical development of CVN424 in Parkinson’s, as there remain significant shortcomings with current therapeutics,” said Brad Margus, chief executive officer of the company.
The study, now enrolling patients, is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial that will evaluate the efficacy and safety of CVN424 in patients with Parkinson’s disease and motor fluctuations who are currently being treated with levodopa. The trial will test two dose levels of CVN424 and is expected to enroll approximately 70 patients. Efficacy endpoints include reduction in “off time,” which refers to periods of the day when Parkinson’s symptoms recur despite medication, as well as other functional outcome measures.
“CVN424 activates key motor pathways, but not the neurons implicated in dyskinesias, a common side effect of dopaminergic Parkinson’s disease treatments,” noted David H. Margolin, M.D., Ph.D., senior vice president of clinical and translational medicine at Cerevance. “This selectivity should allow CVN424 to augment the positive effects of the current standard of care, levodopa, without exacerbating its side effects.”
Mark Carlton, Ph.D., chief scientific officer of Cerevance, added, “This compound exemplifies Cerevance’s approach of identifying and modulating therapeutic targets that are selectively expressed in disrupted circuits or vulnerable neuronal and glial populations in central nervous system diseases.”
Additional information about the study will soon be posted to ClinicalTrials.gov.
CVN424 is an orally bioavailable, brain penetrant small molecule. It acts as a potent modulator of a novel target that is selectively expressed in striatal neurons of the dopamine D2 receptor dependent pathway (the “indirect” pathway) compared to the D1 receptor dependent (“direct”) pathway. The compound improves locomotor activity in animal models of Parkinson’s disease.
Cerevance is a private pharmaceutical company focused on central nervous system diseases. The company’s strengths include its powerful NETSseq target discovery platform, a pipeline of novel discovery-stage and clinical-stage compounds and a proven team. Its scientists believe that they are well positioned to deliver life-changing therapeutics for patients who have brain-related disorders.