AbbVie’s tavapadon meets primary endpoint in Phase 3 Parkinson’s trial

AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s disease. Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease. The trial met its primary endpoint – patients treated with tavapadon in both dose groups experienced a statistically significant reduction from baseline vs. placebo. The TEMPO-1 trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living in both tavapadon dose groups vs. placebo at week 26. The safety profile observed in the TEMPO-1 trial was consistent with prior clinical trials. The majority of adverse events reported were mild to moderate in severity. Full results from the TEMPO-1 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 TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024.