AbbVie has shared promising top-line results from a phase 3 study of its investigational Parkinson’s disease (PD) candidate tavapadon in adults and said it is “on track” to submit a new drug application to the US Food and Drug Administration in 2025.
The TEMPO-2 trial evaluated the D1/D5 dopamine receptor partial agonist as a flexible-dose monotherapy in patients with early stages of the neurodegenerative disorder.
More than ten million people worldwide are living with PD, which is characterised by symptoms such as tremor, muscle rigidity, slowness of movement and difficulty with balance.
TEMPO-2 met its primary endpoint, with tavapadon-treated patients experiencing a statistically significant improvement from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale parts two and three combined score compared to placebo at week 26.
The study’s key secondary endpoint was also met, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living in the tavapadon group compared to placebo at week 26, and the drug’s safety profile was consistent with prior clinical trials.
The update builds on positive top-line results from TEMPO-1, which evaluated two fixed doses of tavapadon, as well as the TEMPO-3 of the drug as an adjunctive therapy to levodopa, which is often viewed as the first-line drug for the management of PD motor symptoms.
AbbVie is also conducting an open-label extension trial, TEMPO-4, to assess the long-term safety and tolerability of the candidate.
Primal Kaur, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie, said: “The positive results across all three phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of PD.
“With this data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease.”
AbbVie gained access to tavapadon earlier this year through its $8.7bn acquisition of Cerevel Therapeutics. The agreement, first announced in December 2023 and completed at the beginning of August, included multiple clinical-stage and preclinical candidates targeting neurological conditions, as well as psychiatric disorders.