AbbVie's (ABBV.US) small molecule therapy tavapadon has met the primary endpoint of its pivotal Phase 3 trial and is expected to file for approval in 2025.

AbbVie (ABBV.US) today announced positive top-line results from its pivotal Phase 3 TEMPO-2 trial. Analysis showed that tavapadon, an investigational small molecule therapy, met the primary endpoint as a flexible dose monotherapy in early Parkinson's disease (PD) patients. Statistically significant improvement from baseline was observed in the MDS-UPDRS Part 2 and 3 combined score at week 26. The full results of the trial will be presented at a future medical meeting, and AbbVie expects to submit a New Drug Application (NDA) to the U.S. FDA in 2025. According to the press release, tavapadon is the first investigational once-daily dopamine D1/D5 receptor partial agonist currently being developed for the treatment of Parkinson's disease.

Tavapadon is an investigational selective D1/D5 receptor partial agonist currently being studied as a monotherapy and as an adjunct to levodopa (LD) for the treatment of Parkinson's disease patients. Tavapadon aims to provide an appropriate balance of motor control, safety, and tolerability by selectively activating the D1/D5 dopamine receptors. By selectively activating the D1/D5 dopamine receptors in the nigrostriatal pathway, tavapadon has the potential to provide an appropriate dopamine signal balance to improve motor control while avoiding the overstimulation of D2/D3 receptors, which is believed to be the cause of many side effects of current dopamine agonists. Additionally, as a partial agonist with a half-life of 24 hours, tavapadon can be taken once daily, avoiding the overactivation of dopamine receptors that causes motor complications.

Last December, AbbVie and Cerevel Therapeutics reached a final agreement for AbbVie to acquire Cerevel for a total of approximately $8.7 billion, gaining access to Cerevel's rich neuroscience pipeline. AbbVie noted in the press release that the efficacy and safety of tavapadon make it a potential complement to AbbVie's existing symptomatic late-stage Parkinson's disease therapy pipeline.