AbbVie said that the Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s disease has met its primary endpoint.
This investigational drug is a D1/D5 dopamine receptor partial agonist, aimed at treating Parkinson’s disease with a once-daily regimen.
AbbVie gained access to tavapadon through the $8.7bn acquisition of Cerevel Therapeutics, which closed last month.
TEMPO-1 was a 27-week Phase 3 double-blind, randomised, placebo-controlled trial.
It evaluated the efficacy and safety of two fixed doses of tavapadon as a monotherapy in early Parkinson’s disease.
The primary endpoint was the change from baseline in the combined Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III score.
Key secondary endpoints included changes in the MDS-UPDRS Part II score and the percentage of patients reporting “much improved” or “very much improved” on the Patient Global Impression of Change (PGIC).
Results showed that patients treated with tavapadon in both dose groups experienced a statistically significant reduction from baseline compared to placebo in patients’ scores on the MDS-UPDRS at week 26.
The trial also met its secondary endpoint, showing meaningful improvements in daily living motor skills (MDS-UPDRS Part II) for both doses compared to placebo at week 26.
The safety profile of the investigational drug in the TEMPO-1 trial was consistent with previous studies. Most adverse events reported were mild to moderate.
AbbVie immunology, neuroscience, eye care, and speciality development senior vice president Primal Kaur said: “This marks a significant step forward in our commitment to enhancing our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition.”
Full results from the TEMPO-1 study will support regulatory submissions for tavapadon as a treatment for Parkinson’s disease.
Additionally, topline results from the TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are anticipated by the end of this year.
The TEMPO clinical development programme is assessing the efficacy, safety, and tolerability of D1/D5 dopamine receptor partial agonist in a diverse Parkinson’s disease population.
This includes TEMPO-1 and TEMPO-2 as two Phase 3 monotherapy trials and one adjunctive trial.
Furthermore, AbbVie is conducting TEMPO-4, an open-label extension trial to evaluate the long-term safety and tolerability of tavapadon.
