Overview
AbbVie has shared positive top-line results from a late-stage study of its investigational Parkinson’s disease (PD) drug in adults.
The TEMPO-1 Trial
The phase 3 TEMPO-1 trial evaluated two fixed doses of the D1/D5 dopamine receptor partial agonist, tavapadon, as a monotherapy for patients with early stages of the neurodegenerative disorder.
About Parkinson’s Disease (PD)
- Epidemiology: - Currently affecting approximately 153,000 people in the UK, PD is characterised by the loss of dopamine-producing neurons in the brain.
- The condition primarily results in progressive and debilitating motor symptoms, including decreased bodily movement, slowness of movement, rigidity, tremors and postural instability.
The Results
- Patients treated with the candidate in both dose groups experienced a statistically significant improvement from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale parts two and three combined score at week 26 compared to placebo, meeting the study’s primary endpoint.
- TEMPO-1 also achieved its key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living in both tavapadon dose groups compared to placebo at week 26.
Result submission: - AbbVie said that full results from the study will be submitted for presentation at future medical meetings and used to support regulatory submissions of the drug.
The update builds on positive top-line results from TEMPO-3, which assessed tavapadon as an adjunctive therapy to levodopa, which is often viewed as the first-line drug for the management of PD motor symptoms.
Phase 3 Results Presentation
Results from the phase 3 study were shared in April and demonstrated a statistically significant increase in total ‘on’ time without troublesome dyskinesia (involuntary, erratic, writhing movements) versus placebo over 27 weeks.
Tavapadon Testing as a Monotherapy
The candidate is also being evaluated as a monotherapy in the phase 3 flexible-dose TEMPO-2 study, for which results are expected by the end of 2024, as well as the open-label extension TEMPO-4 trial.
Satement from the AbbVie
Primal Kaur, senior vice president, immunology, neuroscience, eye care and specialty development at AbbVie, said: “The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further supports the potential of tavapadon for people living with PD… We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial.”
About the Company: AbbVie
- AbbVie gained access to tavapadon this year through its $8.7bn acquisition of Cerevel Therapeutics.
- The definitive agreement, first announced in December 2023, included multiple clinical-stage and preclinical candidates targeting neurological and psychiatric disorders.
