In a phase 2 clinical trial (NCT02847650) participants with early-stage Parkinson’s disease (PD) who were treated with oral tavapadon (Cerevel Therapeutics, Boston, MA) had a 4.8 point improvement in motor symptoms compared with those treated with placebo (least squares mean change; P = .04). Improvement in motor symptoms was measured with the Movement Disorder Society—Unified Parkinson's Disease Rating Scale-3 (MDS-UPDRS-3) at week 15 of the study. The 15-week treatment period included 9 weeks of dose optimization followed by 6 weeks of stable dosing.
On the Patient Global Impression of Change (PGI-C) at week 15, 50% of participants treated with tavapadon reported being “much improved” or “very much improved,” compared with 25% of those treated with placebo.
“The positive phase 2 efficacy and safety data presented today reinforce the potential of tavapadon as a new treatment option for patients with PD,” said Raymond Sanchez, MD, chief medical officer, Cerevel Therapeutics. “Given the favorable profile of tavapadon in clinical studies to date, we see potential for this novel therapy in a variety of treatment settings for PD, both as a monotherapy for patients with early-stage disease and as an adjunct to levodopa for patients with late-stage disease. Over the course of 2020, we plan to initiate a robust phase 3 development program to fully characterize the utility of tavapadon in patients with early- and late-stage PD.”
Tavapadon is an orally administered, selective partial agonist of the dopamine D1 and D5 receptors for the once-daily treatment of symptoms. The randomized, placebo-controlled study enrolled 57 patients, age 45 to 80 with early-stage PD.