The mid-stage trial met the primary endpoint by recording a statistically significant improvement from baseline in motor symptoms in patients treated with tavapadon in comparison with those in the placebo arm. This was on the basis of the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score at 15 weeks.
The phase 2 study, which was a randomised, double-blind, placebo-controlled, and flexible-dose clinical trial, enrolled 57 patients, aged between 45 and 80 years, having early-stage Parkinson’s disease.
At Week 15, the mean change from baseline in the MDS-UPDRS Part III score was -9.0 for tavapadon and for placebo it was -4.3, with a least squares mean improvement over placebo of -4.8 in favour of the investigational drug group.
Cerevel Therapeutics said that its investigational drug showed a favourable safety and tolerability profile, with most of the adverse events reported in the phase 2 study being mild or moderate.
The study results have been presented at the 2019 International Congress of Parkinson’s Disease and Movement Disorders, which is being held in Nice, France.
Cerevel Therapeutics chemistry vice president David Gray said: “Current approaches and treatment options for patients with Parkinson’s disease are often associated with significant complications, troublesome side effects or limited efficacy.
“I’m encouraged by these results, which demonstrated that tavapadon was significantly more effective than placebo in improving motor symptoms and was well tolerated. It has the potential to be a promising new treatment option for people with Parkinson’s disease.”
Cerevel Therapeutics is looking to initiate a phase 3 development program over the course of next year to fully characterise the use of tavapadon in patients having early- and late-stage Parkinson’s.
Cerevel Therapeutics chief medical officer Raymond Sanchez said: “The positive Phase 2 efficacy and safety data presented today reinforce the potential of tavapadon as a new treatment option for patients with Parkinson’s disease.
“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 Parkinson’s disease, both as a monotherapy for patients with early-stage disease and as an adjunct to levodopa for patients with late-stage disease.”
Tavapadon has been designed as a selective partial agonist of the dopamine D1 and D5 receptors.