AbbVie Reports Positive Results in Parkinson's Disease Trial

AbbVie (NYSE: ABBV) today announced that tavapadon, developed for the treatment of early-stage Parkinson's disease, has met its primary and key secondary endpoints in the Phase 3 TEMPO-2 trial. Tavapadon, a new D1/D5 partial agonist, is being investigated as an orally administered treatment taken once daily.

The trial demonstrated that patients receiving flexible doses of tavapadon experienced significant improvements in motor function compared to those receiving a placebo. The primary endpoint was the change in the combined score of the Movement Disorder Society – Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III at week 26. The tavapadon group showed a change of -10.3, while the placebo group recorded a change of -1.2 (p-value <0.001).

Additionally, the study achieved a key secondary endpoint, showing significant improvement in motor aspects of daily living (MDS-UPDRS Part II) for patients treated with tavapadon.

Primal Kaur, M.D., MBA, Senior Vice President at AbbVie, indicated the company's intention to work with regulatory agencies on the next steps to make tavapadon accessible for those with Parkinson's disease, emphasizing its potential to be the first treatment of its class.

The safety profile of tavapadon in the TEMPO-2 trial was consistent with what has been observed in previous clinical trials, with most adverse events being mild to moderate in severity.

Global principal investigator Hubert H. Fernandez, M.D., highlighted the significant burden of Parkinson's disease on individuals and the ongoing need for effective treatments with fewer side effects. He noted that the TEMPO clinical development program indicates that tavapadon could represent an important new treatment option for patients with Parkinson's disease.

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