Biopharmaceutical firm Cerevance has commenced a Phase II clinical trial of its small molecule drug, CVN424, to potentially treat patients with Parkinson’s disease.
CVN424 is designed to specifically regulate a new non-dopaminergic target expressed in a striatal neurons class of the dopamine D2 receptor-dependent pathway. It is orally bioavailable and brain penetrant.
The drug candidate was observed to improve locomotor activity in animal models.
The double-blind, multi-centre, randomised, placebo-controlled Phase II study will assess the safety and efficacy of two CVN424 dose levels in 70 Parkinson’s patients suffering from motor fluctuations and are on levodopa.
Efficacy endpoints of the trial include a decrease in ‘off-time’, defined as periods of the day when disease symptoms recur even after taking medication, along with additional functional outcome measures.
Cerevance clinical and translational medicine senior vice-president David Margolin said: “CVN424 activates key motor pathways, but not the neurons implicated in dyskinesias, a common side effect of dopaminergic Parkinson’s disease treatments.
“This selectivity should allow CVN424 to augment the positive effects of the current standard of care, levodopa, without exacerbating its side effects.”
The company started dosing patients in CVN424’s double-blind, single and multiple ascending dose Phase I trial in September last year. The Phase I study was conducted to assess the safety, tolerability, and pharmacokinetic profile of the drug candidate in 64 healthy individuals.
In April this year, the company announced that the Phase I trial met its primary endpoint of safety. Participants were given 1mg to 225mg single or seven daily doses of CVN424 or placebo.
No serious or severe adverse events or clinically significant changes in vital signs, ECG or laboratory values were observed during the study.