AbbVie Reports Positive Phase 3 TEMPO-2 Results for Tavapadon in Parkinson's Disease

AbbVie recently unveiled promising topline results from its Phase 3 TEMPO-2 trial, which evaluated tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon stands out as the first and only D1/D5 partial agonist being tested for once-daily use in treating Parkinson's disease.

The TEMPO-2 trial assessed the efficacy, safety, and tolerability of tavapadon at doses ranging from 5 mg to 15 mg per day in adults with early-stage Parkinson's disease. The trial successfully met its primary endpoint, demonstrating that patients receiving tavapadon showed 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 those on placebo.

Additionally, the trial achieved a crucial secondary endpoint, with tavapadon recipients experiencing a notable improvement in motor aspects of daily living, as indicated by the MDS-UPDRS Part II score at week 26.

Dr. Primal Kaur, AbbVie’s senior vice president, highlighted the success of the TEMPO-2 trial and its potential to position tavapadon as a pioneering treatment for Parkinson's disease. He expressed eagerness to collaborate with regulatory bodies to bring this innovative therapy to patients.

The safety profile observed in the TEMPO-2 trial aligned with results from earlier studies, with most adverse events being mild to moderate in severity.

Dr. Hubert H. Fernandez, global principal investigator and a movement disorders expert at Cleveland Clinic, underscored the significant burden Parkinson's disease places on individuals and the ongoing need for treatments that effectively manage symptoms while minimizing side effects. He noted that the TEMPO-2 results, along with findings from the broader TEMPO clinical development program, suggest tavapadon could be a valuable new therapeutic option for those affected by Parkinson's disease.

AbbVie plans to present the full results of the TEMPO-2 trial at an upcoming medical conference and is on track to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in 2025.

Parkinson's disease is a chronic neurodegenerative condition marked by progressive motor symptoms such as bradykinesia, rigidity, tremors, and postural instability, primarily due to the degeneration of dopamine-producing neurons in the brain.

Tavapadon, a selective D1/D5 receptor partial agonist, is being studied for its potential as both a monotherapy and an adjunctive therapy to levodopa in treating Parkinson's disease. Its safety and efficacy are still under investigation.

The TEMPO clinical development program, which includes the TEMPO-1, TEMPO-2, and TEMPO-3 Phase 3 trials, assessed tavapadon across a diverse Parkinson's disease population. AbbVie is also conducting the TEMPO-4 open-label extension trial to evaluate the long-term safety and tolerability of the drug.

TEMPO-2, a 27-week, double-blind, randomized, placebo-controlled trial, involved 304 adults with early Parkinson's disease. Participants were randomly assigned to receive either tavapadon (5-15 mg QD) or placebo. The primary endpoint was a change from baseline in the MDS-UPDRS Parts II and III combined score, with key secondary endpoints including the change in the MDS-UPDRS Part II score and the percentage of responders showing significant improvement on the Patient Global Impression of Change (PGIC).

AbbVie remains committed to advancing its neuroscience portfolio, which includes approved treatments for various neurological conditions and a robust pipeline of future therapies. The company aims to make significant contributions to the understanding and treatment of neurological and psychiatric disorders.