AbbVie Announces Positive Topline Results for the Phase 3 TEMPO-2 Trial Evaluating Tavapadon as a Monotherapy for Parkinson's Disease
AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease. The trial met its primary endpoint, showing a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26 compared to placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001). Additionally, it achieved its key secondary endpoint with a significant improvement in motor aspects of daily living (MDS-UPDRS Part II) at week 26. The safety profile was consistent with prior trials, with the majority of adverse events being mild to moderate. AbbVie is on track to submit a New Drug Application (NDA) for tavapadon to the FDA in 2025.
AbbVie ha annunciato risultati positivi preliminari dal suo trial pivotale di Fase 3 TEMPO-2 che valuta tavapadon come monoterapia a dose flessibile nella fase iniziale della malattia di Parkinson. Lo studio ha raggiunto il suo obiettivo principale, mostrando un miglioramento statisticamente significativo rispetto al valore iniziale nel punteggio combinato MDS-UPDRS Parti II e III alla settimana 26 rispetto al placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001). Inoltre, ha raggiunto il suo obiettivo secondario chiave con un significativo miglioramento negli aspetti motori della vita quotidiana (MDS-UPDRS Parte II) alla settimana 26. Il profilo di sicurezza è stato coerente con studi precedenti, con la maggior parte degli eventi avversi considerati lievi o moderati. AbbVie si preparerà a presentare una New Drug Application (NDA) per tavapadon alla FDA nel 2025.
AbbVie anunció resultados positivos preliminares de su ensayo pivotal de Fase 3 TEMPO-2 que evalúa tavapadon como monoterapia a dosis flexible en la fase inicial de la enfermedad de Parkinson. El ensayo cumplió su objetivo primario, mostrando una mejora estadísticamente significativa con respecto a la línea de base en el puntaje combinado MDS-UPDRS Partes II y III en la semana 26 en comparación con el placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; valor p <0.0001). Además, alcanzó su objetivo secundario clave con una mejora significativa en los aspectos motores de la vida diaria (MDS-UPDRS Parte II) en la semana 26. El perfil de seguridad fue consistente con ensayos previos, con la mayoría de los eventos adversos considerados leves a moderados. AbbVie está en camino de presentar una New Drug Application (NDA) para tavapadon a la FDA en 2025.
AbbVie는 초기 파킨슨병에서 타바파돈의 유연한 용량 단일 요법을 평가하는 주요 3상 TEMPO-2 시험에서 긍정적인 주요 결과를 발표했습니다. 이 시험은 주요 목표를 달성했으며, 26주차에 위약 대비 MDS-UPDRS II 및 III 합산 점수에서 기초선 대비 통계적으로 유의미한 개선을 보였습니다 (위약: -1.2; 타바파돈 5-15 mg: -10.3; p-값 <0.0001). 또한, 26주 차에 일상생활의 운동적 측면(MDS-UPDRS Part II)에서 유의미한 개선을 보이며 주요 2차 목표도 달성했습니다. 안전성 프로필은 이전 시험과 일관되었으며, 대부분의 부작용은 경미한 것으로 나타났습니다. AbbVie는 2025년 FDA에 타바파돈에 대한 신약 신청(NDA)을 제출할 계획입니다.
AbbVie a annoncé des résultats préliminaires positifs de son essai pivot de Phase 3 TEMPO-2 évaluant tavapadon comme monothérapie à dose flexible dans les premiers stades de la maladie de Parkinson. L'essai a atteint son objectif principal, montrant une amélioration statistiquement significative par rapport à la ligne de base dans le score combiné MDS-UPDRS Parties II et III à la semaine 26 par rapport au placebo (placebo : -1,2 ; tavapadon 5-15 mg : -10,3 ; valeur p <0,0001). De plus, il a atteint son objectif secondaire clé avec une amélioration significative des aspects moteur de la vie quotidienne (MDS-UPDRS Partie II) à la semaine 26. Le profil de sécurité était cohérent avec des essais antérieurs, la majorité des événements indésirables étant considérés comme légers à modérés. AbbVie prévoit de soumettre une demande de nouveau médicament (NDA) pour tavapadon à la FDA en 2025.
AbbVie hat positive vorläufige Ergebnisse aus der wegweisenden Phase-3-Studie TEMPO-2 veröffentlicht, die tavapadon als flexible Dosis-Monotherapie bei früher Parkinson-Krankheit bewertet. Die Studie erreichte ihr primäres Ziel und zeigte eine statistisch signifikante Verbesserung gegenüber dem Ausgangswert im kombinierten Score der MDS-UPDRS Teile II und III in Woche 26 im Vergleich zur Placebo-Gruppe (Placebo: -1.2; tavapadon 5-15 mg: -10.3; p-Wert <0.0001). Darüber hinaus wurde das wichtigste sekundäre Ziel mit einer signifikanten Verbesserung der motorischen Aspekte des täglichen Lebens (MDS-UPDRS Teil II) in Woche 26 erreicht. Das Sicherheitsprofil war konsistent mit früheren Studien, wobei die Mehrheit der unerwünschten Ereignisse als leicht bis mäßig eingestuft wurde. AbbVie plant, 2025 einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) für tavapadon bei der FDA einzureichen.
- Tavapadon demonstrated statistically significant improvement in MDS-UPDRS Parts II and III combined score.
- Key secondary endpoint of improved motor aspects of daily living also met.
- Safety profile consistent with prior trials with mostly mild to moderate adverse events.
- AbbVie plans to submit an NDA for tavapadon to the FDA in 2025.
- None.
Insights
The Phase 3 TEMPO-2 trial results for tavapadon represent a significant breakthrough in Parkinson's disease treatment. The -10.3 point improvement in MDS-UPDRS Parts II and III combined score versus placebo's -1.2 demonstrates robust efficacy. This is particularly noteworthy as tavapadon is the first D1/D5 partial agonist showing promise in this indication.
The successful achievement of both primary and secondary endpoints, coupled with a favorable safety profile where most adverse events were mild to moderate, positions tavapadon strongly for regulatory review. The flexible dosing range of 5-15mg once daily could offer practical advantages in clinical settings, allowing for personalized treatment optimization.
For AbbVie, tavapadon represents a strategic opportunity to strengthen its neuroscience portfolio. The Parkinson's disease market, valued at over
With the NDA submission planned for 2025, this positive data strengthens AbbVie's near-term pipeline prospects. The successful completion of all three Phase 3 TEMPO trials significantly de-risks the program, potentially adding a valuable revenue stream to offset patent cliffs in other areas.
- 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
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
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
- AbbVie. Data on file ABVRRTI79943.
- 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.
- 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.
- 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
- 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
- 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.
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