AbbVie ABBV announced positive top-line results from the pivotal phase III TEMPO-1 study which evaluated its recently acquired investigational drug tavapadon in adults with early Parkinson’s disease (PD).

The study achieved its primary endpoint, patients who received two fixed doses (5mg and 15mg) of once-daily tavapadon for 26 weeks achieved statistically significant improvement in disease burden. This was measured using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score, a scale developed to evaluate various aspects of PD.

Treatment with the drug also met the key secondary endpoint of statistically significant and clinically meaningful improvement in motor aspects of patients in their daily living across both dose groups for a 26-week treatment period. The safety profile of the drug was also consistent with previously reported clinical studies.

AbbVie intends to use the data from this study when it seeks regulatory approval for tavapadon in PD indication. Management plans to present detailed results from this study at a future medical meeting.

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Year to date, AbbVie’s shares have moved up 23.8% compared with the industry’s 21.6% rise.

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Recent Developments Related to ABBV’s Tavapadon

The TEMPO-1 study is one of the four clinical studies in the late-stage TEMPO clinical development program, which is evaluating tavapadon across a broad PD population.

Earlier this year, AbbVie reported data from the late-stage TEMPO-3 study that evaluated the drug as an adjunctive therapy to levodopa in adult patients with PD. The study met its primary endpoint, the drug, when used as an add-on to levodopa, improved symptom control. Levodopa is the current standard of care for PD symptoms.

The company also plans to report data from the phase III TEMPO-3 study, which is evaluating flexible doses of the drug in early PD patients, by this year’s end. The fourth study, named TEMPO-4, is an open-label extension study to assess the long-term safety and tolerability of the drug in PD patients.

A first-in-class dopamine D1/D5 selective partial agonist, tavapadon was added to AbbVie’s pipeline following the acquisition of Cerevel therapeutics for around $8.7 billion. The completion of this acquisition was announced last month. Through this transaction, management intends to strengthen its neuroscience pipeline by adding Cerevel’s novel pipeline candidates being studied across a range of psychiatric and neurological disorders, which also include schizophrenia and mood disorders.