• Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26¹
• Trial also met its key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score at week 26¹
• Positive results across all three Phase 3 TEMPO trials demonstrate the potential of tavapadon as a first-in-class D1/D5 partial agonist in Parkinson's disease
• AbbVie is on track to submit an NDA for tavapadon to the FDA in 2025

NORTH CHICAGO, Ill., Dec. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease.

The TEMPO-2 trial evaluated the efficacy, safety and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint – patients treated with tavapadon experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001 versus placebo) in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.¹

The TEMPO-2 trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in the tavapadon group (5-15 mg) compared to placebo at week 26.¹

"The positive results across all three Phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson's disease," said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. "With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease."

The safety profile observed in the TEMPO-2 trial was consistent with prior clinical trials.^1,2,6 The majority of adverse events reported were mild to moderate in severity.¹

"Parkinson's disease imposes a profound burden on individuals living with this challenging neurological condition, significantly affecting their quality of life and management of daily activities. Right now, there is still an unmet need for treatments that deliver efficacy while minimizing unwanted side effects," said Hubert H. Fernandez, M.D., global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic. "The results from TEMPO-2, and across the entire TEMPO clinical development program, add to the growing evidence which suggests that tavapadon has the potential to offer an important new option for individuals living with Parkinson's disease."

Full results from the TEMPO-2 trial will be submitted for presentation at a future medical meeting. AbbVie is on track to submit the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in 2025.

About Parkinson's Disease

Parkinson's disease is a chronic neurodegenerative disorder. It primarily results in progressive and debilitating motor symptoms, including decreased bodily movement, slowness of movement, rigidity, tremors and postural instability, all of which result from the loss of dopamine-producing neurons in the brain.³

About Tavapadon

Tavapadon is the first and only selective D1/D5 receptor partial agonist under investigation for Parkinson's disease and is currently being studied as a once-daily medicine for use as both a monotherapy and as an adjunctive therapy to levodopa. The safety and efficacy of investigational tavapadon has not been established.

TEMPO Clinical Development Program

The TEMPO clinical development program evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). AbbVie is also conducting a fourth, open-label extension (OLE) trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon.

TEMPO-2 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of flexible doses of tavapadon (5-15 mg QD) as a monotherapy in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score. Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC).

The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.⁴ Part II contains 13 sub-scores for the motor experiences of daily living and Part III contains 33 sub-scores based on 18 items, several with right, left or other body distribution scores for the motor examination. The sub-score for each is summed to calculate the total scores. The scale range for Part II+III Total Score is 0-184 (Part II maximum total score of 52 + Part III maximum total score of 132). The higher the score the greater the severity. A negative change from baseline represents an improvement in motor function.⁵

A total of 304 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon 5-15 mg QD or placebo, orally and once daily.

AbbVie plans to submit an NDA for tavapadon leveraging data from the TEMPO program to the FDA in 2025.

More information on the TEMPO trials can be found on www.clinicaltrials.gov:

TEMPO-1: NCT04201093
TEMPO-2: NCT04223193
TEMPO-3: NCT04542499
TEMPO-4: NCT04760769 

About AbbVie in Neuroscience

At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners and clinicians. For more information, visit www.abbvie.com.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

References

1. AbbVie. Data on file ABVRRTI79943. 
2. Riesenberg R., Werth J., Zhang Y., Duvvuri S., Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: A randomized, placebo-controlled trial. Ther. Adv. Neurol. Disord. 2020;13:1756286420911296. doi: 10.1177/1756286420911296.
3. DeMaagd G, Philip A. Parkinson's Disease and Its Management: Part 1: Disease Entity, Risk Factors, Pathophysiology, Clinical Presentation, and Diagnosis. P T. 2015 Aug;40(8):504-32. PMID: 26236139; PMCID: PMC4517533.
4. MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). International Parkinson and Movement Disorder Society. Accessed on September 20, 2024. https://www.movementdisorders.org/MDS/MDS-Rating-Scales/MDS-Unified-Parkinsons-Disease-Rating-Scale-MDS-UPDRS.htm
5. Flexible-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-2). National Library of Medicine. Accessed on December 2, 2024. https://clinicaltrials.gov/study/NCT04223193
6. Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018;7(2):307-319. doi: 10.1007/s40120-018-0114-z.