AbbVie ABBV announced positive top-line results from the pivotal phase III TEMPO-2 study, which evaluated its recently acquired investigational drug tavapadon in adults with early Parkinson’s disease (PD).
The study achieved its primary endpoint, as patients who received flexible doses (ranging from 5mg to 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.
The above results were in line with the positive results from the late-stage TEMPO-1 reported earlier in September that evaluated fixed doses (5mg and 15mg) of once-daily tavapadon for 26 weeks in adults with early PD. The study achieved its primary endpoint of statistically significant improvement in disease burden.
AbbVie intends to use the data from both these studies when it seeks regulatory approval for tavapadon in PD indication next year. Management plans to present full results from the TEMPO-1 study at a future medical meeting.
ABBV Stock’s Performance
Year to date, AbbVie’s shares have moved up 14% compared with the industry’s 9.5% growth.
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Recent Developments Related to ABBV’s Tavapadon
The TEMPO-1 and TEMPO-2 studies are two of the four clinical studies in the late-stage TEMPO clinical development program 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, treatment with the drug, when used as an add-on to levodopa, improved symptom control. Levodopa is the current standard of care for PD symptoms. Management also plans to use this data alongside the TEMPO-1 and TEMPO-2 studies when it seeks FDA approval for the drug in PD indication.
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 in August. 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.
ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
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Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
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AbbVie Inc. (ABBV) : Free Stock Analysis Report
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Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report
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