Positive topline results for tavapadon in phase III adjunctive trial for people living with Parkinson’s disease

The TEMPO-3 trial  evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults. The trial met its primary endpoint – patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs. 0.6 hours, p <0.0001). a statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm.>

“Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability,” said Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics. “We are highly encouraged with the resultsand look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease.”

Tavapadon was generally well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon. The majority of adverse events reported were mild to moderate in severity.

“Parkinson’s disease is the fastest growing neurodegenerative disorder in the world, and a significant need exists for a new treatment option that provides the right balance of dopamine signaling and delivers sustained motor control without the burdensome side effects associated with current treatments," said Hubert H. Fernandez, M.D., global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic. “The results from the TEMPO-3 trial are particularly exciting as they demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease.”

Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease. Topline results from the Phase III monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of 2024.

On December 6, 2023, Cerevel announced that it had entered into an agreement to be acquired by AbbVie. Cerevel continues to expect the merger to close in the middle of 2024, subject to receipt of regulatory approvals and other customary closing conditions specified in the merger agreement.