Phase 3 TEMPO-1 Trial Reports Positive Results on Tavapadon for Parkinson Disease
Tavapadon, an investigational D1/D5 dopamine receptor partial agonist for Parkinson disease (PD), met both the primary and secondary endpoints in the phase 3 TEMPO-1 clinical trial, drug manufacturer Abbvie recently announced.
Earlier this year, Cerevel Therapeutics announced positive results from the TEMPO-3 trial. Patients with PD and motor fluctuations receiving once-daily tavapadon as an adjunct therapy to levodopa reported a significant increase in total daily “on” time, or the amount of time PD medications effectively control motor and non-motor symptoms.
"The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson's disease," said Primal Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye care, and specialty development, AbbVie.
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The TEMPO-1 trial evaluated 2 daily doses (5-mg and 15-mg) of tavapadon as a monotherapy in adults with early PD. Patients treated with the drug in both dosage groups reported a significant reduction from baseline on the Movement Disorder Society – Unified Parkinson Disease Rating Scale (MDS-UPDRS) parts II and III combined score at week 26 (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p-value <0.0001 each dose versus placebo).
Patients receiving tavapadon also showed a “statistically significant and clinically meaningful improvement” in the motor aspects of daily life across both dosage groups.
AbbVie reported that the safety profile was consistent with prior clinical trials. The most common treatment-related adverse effects (TEAEs) reported in TEMPO-3 were nausea, dyskinesia, dizziness, headache, orthostatic hypotension, and visual hallucinations. Additionally, there were 17 serious TEAEs reported in patients receiving tavapadon, but details have not been widely reported.
Topline results from TEMPO-2, the phase 3 flexible-dose tavapadon monotherapy trial including 296 patients with early PD, are expected by the end of 2024.
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