AbbVie's Parkinson's drug from Cerevel succeeds in Phase 3

AbbVie has reported positive results from a Phase 3 trial for tavapadon, a drug aimed at treating Parkinson's disease, which it acquired through its recent purchase of Cerevel. The latest data, gathered from the TEMPO-1 study, evaluated tavapadon as a standalone treatment and showed significant improvements in patients' conditions.

The TEMPO-1 study results indicated that both tested doses of tavapadon met the primary endpoint by demonstrating significant improvements on the MDS-UPDRS scale, which assesses motor and non-motor symptoms of Parkinson's disease. After 26 weeks, the study found that a 5 mg dose of tavapadon led to an average improvement of -9.7 points on the MDS-UPDRS scale, while a 15 mg dose resulted in an average improvement of -10.2 points. In comparison, the placebo group experienced an average increase of 1.8 points in their scores. These improvements were statistically significant, with both doses achieving a p-value of less than 0.0001.

Tavapadon is a selective dopamine D1/D5 receptor partial agonist initially developed by Pfizer. However, Pfizer halted its development in 2017, and it was later spun out to form Cerevel the following year. AbbVie finalized its acquisition of Cerevel last month, incorporating tavapadon into its portfolio.

The positive results from the TEMPO-1 study come on the heels of another success in April, when the Phase 3 TEMPO-3 study showed efficacy as an adjunctive treatment for adults with late-stage Parkinson's disease who are already undergoing levodopa therapy. Additionally, another trial, the Phase 3 TEMPO-2 study, is currently underway. This study is examining tavapadon as a flexible-dose monotherapy and is expected to report results by the end of the year.

Although AbbVie executives have highlighted that emraclidine, a drug for schizophrenia, represents a substantial portion of the value from the Cerevel acquisition, tavapadon remains the most advanced project in AbbVie's pipeline. Despite the promising results, AbbVie has not disclosed its timeline for seeking FDA approval for tavapadon.