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AbbVie Announces Positive Topline Results from Phase 3 TEMPO-1 Trial Evaluating Tavapadon as a Monotherapy for Parkinson's Disease

Published: 2024-09-26 12:00:00 ET
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  • Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26
  • Trial also met key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score
  • Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a flexible-dose monotherapy, are expected by the end of 2024

NORTH CHICAGO, Ill., Sept. 26, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive 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.

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. 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; p-value

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