AbbVie Says Pivotal Trial For Parkinson's Candidate Meets Its Primary Goal In Patients With Early Disease

Zinger Key Points

Tavapadon 5 mg and 15 mg doses showed significant reductions in MDS-UPDRS scores at week 26, compared to placebo.
AbbVie plans to present the full results at medical conferences and expects additional trial data from TEMPO-2 by the end of 2024.
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On Thursday, AbbVie Inc ABBV released topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson’s disease.

Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease. AbbVie added the drug candidate with its $8.7 billion buyout of Cerevel Therapeutics.

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 in adults with early Parkinson’s disease.

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The trial met its primary endpoint – patients treated with tavapadon in both dose groups experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2 versus placebo) in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.

MDS-UPDRS assesses motor and non-motor symptoms of Parkinson’s disease.

The TEMPO-1 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 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.

Full results from the TEMPO-1 study will be submitted 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.

Price Action: ABBV stock is up 0.33% at $191.90 at the last check on Wednesday.

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