Cerevel Therapeutics Announces Positive Topline Results for Tavapadon in Phase 3 Adjunctive Trial for People Living with Parkinson’s Disease

Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks

Results demonstrate tavapadon’s potential to provide the right balance of motor control, safety and tolerability for people living with Parkinson’s disease

Additional data from the trial will be presented at a future medical meeting; results from the tavapadon Phase 3 monotherapy trials (TEMPO-1 and TEMPO-2) are expected in the second half of 2024

CAMBRIDGE, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as a once-daily treatment for 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 results announced today, and 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.”