Results from TEMPO-1, which showed that tavapadon significantly improved motor symptoms in patients with Parkinson’s disease, will help AbbVie as it builds a regulatory case for the D1/D5 dopamine receptor agonist.
AbbVie on Thursday announced that its investigational Parkinson’s disease drug tavapadon met its primary efficacy endpoint in the Phase III TEMPO-1 trial, showing significant improvements in motor and non-motor symptoms in patients with early-stage disease.
At week 26, patients given the 5-mg tavapadon monotherapy demonstrated 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 together assess various motor domains. Placebo counterparts, on the other hand, saw a 1.8-point deterioration in scores. The treatment effect was statistically significant in favor of tavapadon, with a p-value of less than 0.0001, according to AbbVie.
At a higher dose of 15 mg, tavapadon improved MDS-UPDRS parts II and III scores by 10.2 points, which was significantly better than that in the placebo group.
Tavapadon monotherapy also hit its secondary efficacy endpoint of significant and clinically meaningful improvements in motor experiences of daily living. In terms of safety, TEMPO-1 found tavapadon to be well-tolerated, with most side effects being mild or moderate in severity.
Primal Kaur, AbbVie’s senior vice president for immunology, neuroscience, eye care and specialty development, in a statement said that the findings “support the potential of tavapadon for patients living with Parkinson’s disease,” noting that the readout marks a “significant step forward” for its Parkinson’s portfolio.
AbbVie will present Thursday’s findings at an upcoming medical congress and will use the data to support a regulatory filing for tavapadon in Parkinson’s disease.
Tavapadon is a selective partial agonist of the D1/D5 dopamine receptors with first-in-class potential for Parkinson’s disease treatment. The D1/D5 subtypes of dopamine receptors are directly responsible for regulating motor activity, and tavapadon’s mechanism of action allows it to target motor pathways in the brain while only minimally triggering potential side effects, such as hallucinations and sleepiness.
Tavapadon was originally developed by Cerevel Therapeutics, which AbbVie acquired for $8.7 billion in December 2023. The companies formally completed the deal last month.
In April 2024, Cerevel published data from the Phase III TEMPO-3 trial, which also tested tavapadon in Parkinson’s disease but in combination with levodopa. Results showed that at 27 weeks, the drug combo increased “on” time without trouble dyskinesia by 1.7 hours versus 0.6 hours in placebo. In Parkinson’s disease, “on” time refers to periods during which patients have good symptom control.
AbbVie is also running the TEMPO-4 trial, which will assess the long-term safety and tolerability of tavapadon, and the TEMPO-2 study, which is looking at a flexible-dose regimen of tavapadon monotherapy. Topline data from the latter study are set to come out by the end of 2024.
