Cerevel Therapeutics’ tavapadon meets Phase 3 primary endpoint in Parkinson’s

Cerevel Therapeutics 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 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. A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm. 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. 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 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of 2024.