The Phase III TEMPO-1 trial evaluated two daily doses of tavapadon (5mg and 15mg) in 529 Parkinson’s patients. Credit: Pixel-Shot via Shutterstock.

AbbVie’s recently acquired Parkinson’s disease candidate tavapadon significantly reduced the burden of disease in a Phase III trial.

The Phase III TEMPO-1 trial (NCT04201093) evaluated two daily doses of tavapadon (5mg and 15mg). The trial met its primary endpoint, with both dose groups outperforming placebo in improving disease burden at week 26, as measured by a combined score from the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

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Tavapadon also reached a key secondary endpoint, with both dose groups showing statistically significant and clinically meaningful improvement in motor aspects of daily living (MDS-UPDRS Part II) compared to placebo. The safety profile observed in the TEMPO-1 trial was consistent with prior clinical trials.

AbbVie inherited tavapadon in August 2023 after it acquired Cerevel Therapeutics in an $8.7bn deal. The drug candidate is being evaluated in four clinical trials, dubbed TEMPO-1 to 4.

These results build on positive topline results from the Phase III TEMPO-3 (NCT04542499) clinical trial, announced in April 2024. The trial evaluated a once-a-day dose of tavapadon to treat Parkinson’s as an adjunctive treatment to levodopa (LD) in 507 patients aged 40-80 years. The trial met its primary endpoint and key secondary endpoints.

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AbbVie’s senior vice president of immunology, neuroscience, eye care and speciality development 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.”

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Tavapadon is an oral dopamine receptor agonist drug which targets dopamine D1 and D5 receptors. Inappropriate stimulation of D1 and D5 receptors results in the impairment of cognitive functions. The drug candidate enhances the agonist-stimulated receptor signals to raise the levels of extracellular brain acetylcholine (ACh), improving cognitive function.

According to GlobalData’s Pharma Intelligence Center, tavapadon could generate up to $673m in 2030 if it secures regulatory approval.

GlobalData is the parent company of Clinical Trials Arena.

Parkinson’s is a chronic neurodegenerative disorder that affects movement control. The current treatments for Parkinson’s are limited to providing symptomatic relief of motor symptoms, citing an unmet need for disease-modifying therapies. Roche is developing prasinezumab, a potentially disease-modifying monoclonal antibody. The candidate is currently being investigated in the Phase II PASADENA trial (NCT03100149).