AbbVie reports positive phase 3 results for Parkinson's monotherapy

AbbVie has announced positive topline results from its phase 3 TEMPO-1 trial evaluating tavapadon as a monotherapy for early Parkinson’s disease.

The trial met its primary endpoint, showing significant improvement in motor function, as measured by the MDS-UPDRS Parts II and III combined score, at week 26.

The trial also achieved its key secondary endpoint, with tavapadon improving patients' motor aspects of daily living. Both the 5 mg and 15 mg doses outperformed placebo in these measures.

AbbVie plans to use the data to support regulatory submissions for tavapadon as a treatment for Parkinson's disease. Additional results from the phase 3 TEMPO-2 trial are expected by the end of 2024.

Tavapadon, the first and only D1/D5 receptor partial agonist under investigation as a once-daily treatment for Parkinson’s disease, features a novel mechanism by selectively activating D1/D5 dopamine receptors. Despite its recent progress, it wasn’t the key asset in AbbVie's $8.7 billion acquisition announced last December. At that time, AbbVie had spotlighted emraclidine, Cerevel's positive allosteric modulator, currently in phase 2 trials for schizophrenia.