AbbVie's Parkinson's drug tavapadon promising in phase 3 trial

AbbVie recently announced encouraging results from a phase 3 clinical trial for its experimental Parkinson's disease (PD) treatment, tavapadon. The biopharmaceutical company is preparing to submit a new drug application to the US Food and Drug Administration by 2025. Tavapadon, a D1/D5 dopamine receptor partial agonist, was evaluated in the TEMPO-2 trial as a flexible-dose monotherapy for patients in the early stages of PD, a disorder affecting over ten million individuals globally. Common symptoms of Parkinson's include tremors, muscle stiffness, slowed movement, and balance difficulties.

The TEMPO-2 trial successfully met its primary endpoint. Patients treated with tavapadon showed a statistically significant improvement in their Movement Disorder Society – Unified Parkinson’s Disease Rating Scale scores, parts two and three combined, compared to those receiving a placebo after 26 weeks. Furthermore, the trial reached its key secondary endpoint, with patients in the tavapadon group experiencing a noteworthy enhancement in motor aspects related to daily living activities compared to the placebo group. The safety profile of tavapadon was consistent with findings from previous clinical trials.

These promising results build on earlier positive outcomes from the TEMPO-1 trial, which investigated two fixed doses of the drug. Additionally, the TEMPO-3 trial assessed tavapadon as an adjunctive therapy alongside levodopa, a common first-line treatment for managing PD motor symptoms. To further evaluate the long-term safety and tolerability of the drug, AbbVie is conducting an open-label extension study, known as TEMPO-4.

Primal Kaur, AbbVie’s senior vice president of immunology, neuroscience, eye care, and specialty development, expressed optimism regarding the results of the TEMPO trials. Kaur highlighted the potential of tavapadon as a pioneering treatment option for Parkinson’s disease. With these findings, the company aims to collaborate with regulatory agencies to determine subsequent steps, bringing them closer to making tavapadon available to individuals affected by this chronic and debilitating illness.

AbbVie acquired tavapadon earlier in 2023 through a strategic acquisition of Cerevel Therapeutics, a deal worth $8.7 billion. The acquisition, which was first unveiled in December 2023 and concluded in early August, included multiple clinical-stage and preclinical candidates targeting neurological and psychiatric disorders. Through this acquisition, AbbVie has expanded its portfolio, emphasizing its commitment to developing innovative treatments for neurological conditions, including Parkinson’s disease.

The strong results from the TEMPO-2 trial underscore the potential role of tavapadon in improving the quality of life for individuals with Parkinson’s disease, marking a significant step forward in PD treatment. As AbbVie prepares for regulatory submissions, the company remains focused on its mission to deliver novel therapeutic options to patients worldwide, ultimately aiming to address unmet needs in the field of neurology.