AbbVie Inc. (ABBV) released positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s disease. Tavapadon, acquired through AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics, is an investigational D1/D5 dopamine receptor partial agonist being developed as a once-daily treatment for Parkinson’s disease.
The TEMPO-1 trial evaluated the efficacy, safety, and tolerability of two fixed doses (5 mg and 15 mg, once daily) of tavapadon in adults with early Parkinson’s disease. The primary endpoint of the trial was met, with patients treated with both doses of tavapadon experiencing a statistically significant improvement in their Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26 compared to placebo. The MDS-UPDRS assesses both motor and non-motor symptoms of Parkinson’s disease.
The trial also met its key secondary endpoint, showing a statistically significant and clinically meaningful improvement in motor aspects of daily living (MDS-UPDRS Part II) in both tavapadon dose groups compared to placebo at week 26. The safety profile observed in the TEMPO-1 trial was consistent with previous clinical trials, with most adverse events reported as mild to moderate in severity.
AbbVie plans to submit the full results from the TEMPO-1 study for presentation at future medical meetings and to support regulatory submissions for tavapadon as a treatment for Parkinson’s disease. Topline results from TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are anticipated by the end of 2024.
These promising results suggest that tavapadon could offer a new treatment option for patients with early Parkinson’s disease. Further investigation and regulatory approval are necessary to confirm its effectiveness and safety in the long term.
