AbbVie: Tavapadon Meets Primary, Secondary Endpoints In Phase 3 Trial In Early Parkinson's Disease

(RTTNews) - Drugmaker AbbVie (ABBV) announced Thursday positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease.

The company plans to submit full results from the TEMPO-1 study for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson's disease.

Topline results from TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024.

Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment for Parkinson's disease.

The TEMPO-1 trial evaluated the efficacy, safety and tolerability of two fixed doses (5 mg and 15 mg, once daily) of tavapadon as a monotherapy.

The trial met its primary endpoint, with a statistically significant reduction (improvement) from baseline compared to placebo in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale or MDS-UPDRS Parts II and III combined score at week 26.

The trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in both tavapadon dose groups compared to placebo at week 26.

The company noted that the safety profile observed in the TEMPO-1 trial was consistent with prior clinical trials. The majority of adverse events reported were mild to moderate in severity.

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