The company is evaluating the use of tavapadon in patients with Parkinson’s disease.

Tavapadon is a potent, orally-bioavailable, selective partial agonist of the dopamine D1 and D5 receptors.

It is being evaluated as a once-daily symptomatic treatment of Parkinson’s disease.

Cerevel will conduct three 27-week trials designed to evaluate the efficacy, safety and tolerability of fixed doses and flexible doses of tavapadon; as either a single  therapy in patients with early-stage Parkinson’s disease or as an adjunctive one in patients with late-stage Parkinson’s experiencing motor fluctuations.

A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

“Parkinson’s disease affects approximately 10 million people worldwide, and there remains an important need for better and more effective therapies across the spectrum of this debilitating disease,” says Raymond Sanchez, chief medical officer of Cerevel Therapeutics.

“We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage Parkinson’s. It is our expectation that the innovative design of each of these Phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning. We anticipate data from these trials to be available beginning in the second half of 2022.”

The three double-blind, randomized, placebo-controlled, parallel-group Phase 3 clinical trials will enroll patients ages 40 to 80 years with either early-stage Parkinson’s disease (TEMPO-1, TEMPO-2) or patients with late-stage Parkinson’s disease who are experiencing motor fluctuations on levodopa treatment (TEMPO-3).

Approximately 1,200 patients will be enrolled across all three trials.

Approximately 10 million people worldwide are living with Parkinson’s disease, according to the Parkinson’s Foundation.

The disease is characterised by a progressive degeneration of dopaminergic neurons (the main source of dopamine) leading to a loss of critical motor and non-motor functions.

Symptom severity and disease progression differ between individuals but typically include slowness of movement (bradykinesia), trembling in the extremities (tremors), stiffness (rigidity), cognitive or behavioral abnormalities, sleep disturbances and sensory dysfunction.1

There is no laboratory or blood test for Parkinson’s disease, so a diagnosis is made based on clinical observation,2 which may contribute to an underestimation of the incidence of the disease.

Cerevel Therapeutics seeks to unlock the science surrounding new treatment opportunities through understanding the neurocircuitry of neuroscience diseases and associated symptoms

It has a pipeline comprising five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia and substance use disorder.

The firm is headquartered in Boston, US.