US-based pharmaceutical company AbbVie (NYSE: ABBV) has revealed positive top-line results from the pivotal Phase III TEMPO-2 study for its tavapadon, the world’s first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson’s disease (PD).
TEMPO-2 Trial Design and Outcomes
The TEMPO-2 trial assessed the efficacy, safety, and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with tavapadon as a monotherapy in adults with early PD. The study successfully met its primary endpoint, showing that patients treated with tavapadon experienced a statistically significant reduction from baseline compared to placebo in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. The results were as follows: placebo (-1.2); tavapadon 5-15 mg (-10.3); with a p-value of less than 0.0001 versus placebo. The safety profile of tavapadon was consistent with prior clinical trials.
Implications for New Drug Application and Parkinson’s Treatment
These positive results will support the submission of a New Drug Application (NDA) for tavapadon to the US Food and Drug Administration (FDA), which is expected to take place in 2025. The successful outcomes of the TEMPO-2 study could lead to a new treatment option for patients with early PD, offering a potential alternative to existing therapies.-Fineline Info & Tech
