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AbbVie's Tavapadon Phase 3 Trial Shows Significant Progress In Parkinson's Disease Treatment

AbbVie’s Phase 3 TEMPO-2 trial showed tavapadon significantly improved motor function in early-stage Parkinson’s disease.

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  • Dec 10, 2024

  • Simantini Singh Deo

AbbVie's Tavapadon Phase 3 Trial Shows Significant Progress In Parkinson's Disease Treatment

AbbVie has shared promising topline results from its Phase 3 TEMPO-2 trial, which evaluated tavapadon as a once-daily treatment for early-stage Parkinson's disease. Tavapadon is the first D1/D5 partial agonist in development for Parkinson's.

The study examined the effectiveness, safety, and tolerability of flexible-dose tavapadon, ranging from 5 to 15 mg daily as a stand-alone therapy. Over 26 weeks, patients receiving tavapadon showed significant improvement compared to those on placebo, with a marked reduction in scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined. Specifically, the score improvement was -10.3 in the tavapadon group versus -1.2 for placebo, achieving a highly significant p-value of less than 0.0001.

Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and speciality development, AbbVie, said in a statement, "The positive results across all three Phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson's disease. With these data in hand, we look forward to working with regulatory agencies to assess the next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease."

"Parkinson's disease imposes a profound burden on individuals living with this challenging neurological condition, significantly affecting their quality of life and management of daily activities. There is still an unmet need for effective treatments while minimising unwanted side effects. The results from TEMPO-2, and across the entire TEMPO clinical development program, add to the growing evidence which suggests that tavapadon has the potential to offer an important new option for individuals living with Parkinson's disease," stated Hubert H. Fernandez, M.D., global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic.

The trial also reached a key secondary goal, demonstrating substantial and meaningful improvements in patients’ motor abilities in daily activities (measured by MDS-UPDRS Part II). The safety findings aligned with earlier studies, with most reported mild to moderate side effects. AbbVie plans to present the complete data at an upcoming medical conference and remains on track to submit a New Drug Application (NDA) to the FDA for Tavapadon to the FDA in 2025.

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