US pharmaceutical company AbbVie (NYSE: ABBV) on Thursday announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease.

Tavapadon, an investigational D1/D5 dopamine receptor partial agonist, is being studied as a once-daily treatment for Parkinson's disease.

The TEMPO-1 trial assessed the efficacy, safety and tolerability of two fixed doses (5 mg and 15 mg, once daily) of tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint, with patients treated with tavapadon in both dose groups experiencing a statistically significant reduction (improvement) 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.

Additionally, the key secondary endpoint of the trial was met by demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in both tavapadon dose groups compared to placebo at week 26.

Primal Kaur, MD, MBA, senior vice president of immunology, neuroscience, eye care and specialty development at AbbVie, said: "The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson's disease. This marks a significant step forward in our commitment to enhancing our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition. We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial."