AbbVie's $8.2 billion Parkinson's drug shines in Phase III trial

The phase III TEMPO-1 study evaluated two daily doses of tavapadone (5 mg and 15 mg) in 529 Parkinson's patients. Image credit: Pixel shot via Shutterstock.

AbbVie's recently acquired Parkinson's disease candidate tavapadone significantly reduced disease burden in a Phase III study.

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

Tavapadone also met a key secondary endpoint: both dose groups demonstrated 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 study was consistent with previous clinical studies.

AbbVie inherited tavapadone in August 2023 after acquiring Cerevel Therapeutics in an $8.7 billion deal. The drug candidate is being evaluated in four clinical trials called TEMPO-1 to 4.

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

Primal Kaur, senior vice president of immunology, neuroscience, eye care and specialty development at AbbVie, said: “This represents a significant step forward in our commitment to expanding our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and underscores our commitment to supporting patients at all.” Stages of this challenging neurological disease.”

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Tavapadone is an oral dopamine receptor agonist medication that targets the dopamine D1 and D5 receptors. Improper stimulation of D1 and D5 receptors leads to impaired cognitive functions. The drug candidate enhances receptor signals stimulated by agonists to increase levels of extracellular acetylcholine (ACh) in the brain, thereby improving cognitive function.

According to GlobalData's Pharma Intelligence Center, tavapadone could generate up to $673 million in 2030 if it receives regulatory approval.

GlobalData is the parent company of Clinical trial arena.

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