AbbVie's Early Parkinson's Candidate Hits Primary Goal In Pivotal Late-Stage Study

On Monday, AbbVie Inc. ABBV revealed topline results from its pivotal Phase 3 TEMPO-2 trial, which evaluated investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease.

Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease.

The TEMPO-2 trial evaluated the efficacy, safety and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with 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 experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001 versus placebo) in the Movement Disorder Society – Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.

The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications.

The TEMPO-2 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 the tavapadon group (5-15 mg) compared to placebo at week 26.

The safety profile observed in the TEMPO-2 trial was consistent with prior clinical trials. The majority of adverse events reported were mild to moderate in severity.

Full results from the TEMPO-2 trial will be submitted for presentation at a future medical meeting. AbbVie is on track to submit the New Drug Application to the FDA in 2025.

Last month, AbbVie reported two trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia failed two Phase 2 trials.

The studies did not meet their primary endpoint of showing a statistically significant improvement in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6.

Price Action: ABBV stock is up 0.86% at $177.71 at last check Monday.

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