AbbVie's $8.7B Cerevel Purchase Pays Off With Phase III Parkinson's Success

AbbVie has announced that its investigational drug tavapadon has met its primary efficacy endpoint in the Phase III TEMPO-1 trial for Parkinson’s disease. The trial results revealed significant improvements in both motor and non-motor symptoms for patients in the early stages of the disease.

Evaluations at the 26th week of treatment showed that patients treated with a 5-mg dose of tavapadon experienced a 9.7-point improvement in their combined scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III, which assess various motor domains. In contrast, the placebo group saw a 1.8-point deterioration in their scores. The statistical significance of the treatment effect for tavapadon was confirmed with a p-value of less than 0.0001.

Moreover, patients administered a higher dose of 15 mg of tavapadon showed an even greater improvement, with a 10.2-point gain in their MDS-UPDRS parts II and III scores, which was significantly better compared to the placebo group. The drug also successfully met its secondary efficacy endpoint, showing significant improvements in motor experiences during daily living activities.

Regarding safety, the TEMPO-1 trial found tavapadon to be well-tolerated, with most side effects classified as mild or moderate in severity. According to Primal Kaur, AbbVie’s senior vice president for immunology, neuroscience, eye care, and specialty development, these findings support the potential of tavapadon for people living with Parkinson’s disease and represent a significant step forward for AbbVie’s Parkinson’s portfolio.

AbbVie plans to present the findings at an upcoming medical congress and use the data to support a regulatory filing for tavapadon as a treatment for Parkinson’s disease. Tavapadon is known as a selective partial agonist of the D1/D5 dopamine receptors and holds first-in-class potential for treating Parkinson’s disease. The drug targets motor pathways in the brain while minimizing side effects such as hallucinations and sleepiness.

Originally developed by Cerevel Therapeutics, tavapadon became part of AbbVie’s portfolio following its acquisition of Cerevel for $8.7 billion in December 2023. The acquisition deal was formally completed last month. In April 2024, Cerevel published data from the Phase III TEMPO-3 trial, which tested tavapadon in combination with levodopa for Parkinson’s disease. The combination treatment increased "on" time without troublesome dyskinesia by 1.7 hours compared to 0.6 hours for the placebo.

In addition to TEMPO-1 and TEMPO-3, AbbVie is conducting the TEMPO-4 trial to assess the long-term safety and tolerability of tavapadon, as well as the TEMPO-2 study, which is investigating a flexible-dose regimen of tavapadon monotherapy. Topline data from the TEMPO-2 study are expected by the end of 2024.