AbbVie announced positive topline results from its pivotal phase 3 trial evaluating its only D1/D5 partial agonist, tavapadon, as a flexible-dose monotherapy in early Parkinson's disease.
The TEMPO-2 trial, which evaluated the efficacy, safety and tolerability of a flexible-dose (5 mg to 15 mg tablet) once-daily treatment with tavapadon, met its primary endpoint — at week 26, patients treated with tavapadon experienced 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.
The trial also met its key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in the tavapadon group compared to placebo at week 26.
Data in hand, AbbVie says it is on track to submit a New Drug Application to the U.S. FDA in 2025.
AbbVie picked up tavapadon through its $8.7 billion acquisition of Cerevel Therapeutics announced in December 2023. Despite its success in late-stage trials at the time, tavapadon was not the standout asset in the deal, with AbbVie instead highlighting emraclidine, Cerevel's positive allosteric modulator that was in phase 2 trials for schizophrenia. AbbVie recently revealed that emraclidine failed to meet endpoints in a pair of phase 2 trials.