AbbVie Announces Positive Topline Results from Phase 3 TEMPO-1 Trial Evaluating Tavapadon as a Monotherapy for Parkinson's Disease
AbbVie (NYSE: ABBV) has announced positive topline results from its Phase 3 TEMPO-1 trial for tavapadon, an investigational D1/D5 dopamine receptor partial agonist, as a monotherapy for early Parkinson's disease. The trial met its primary endpoint, showing statistically significant improvements in the MDS-UPDRS Parts II and III combined score at week 26 for both 5 mg and 15 mg doses compared to placebo. It also met a key secondary endpoint, demonstrating significant improvement in the MDS-UPDRS Part II score. The safety profile was consistent with prior clinical trials, with most adverse events being mild to moderate. Full results will be submitted for presentation at future medical meetings and used for regulatory submissions. Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a flexible-dose monotherapy, are expected by the end of 2024.
AbbVie (NYSE: ABBV) ha annunciato risultati positivi preliminari dal suo studio di fase 3 TEMPO-1 per tavapadon, un agonista parziale dei recettori dopaminergici D1/D5 in fase di sperimentazione, come monoterapia per il morbo di Parkinson precoce. Lo studio ha raggiunto il principale obiettivo, mostrando miglioramenti statisticamente significativi nel punteggio combinato delle Parti II e III dell'MDS-UPDRS alla settimana 26 per entrambe le dosi da 5 mg e 15 mg rispetto al placebo. Ha inoltre raggiunto un importante obiettivo secondario, dimostrando un significativo miglioramento nel punteggio della Parte II dell'MDS-UPDRS. Il profilo di sicurezza è stato coerente con studi clinici precedenti, con la maggior parte degli eventi avversi classificati come lievi o moderati. I risultati completi saranno presentati in future conferenze mediche e utilizzati per le sottomissioni regolatorie. I risultati dello studio di fase 3 TEMPO-2, che studia tavapadon come monoterapia a dose flessibile, sono attesi entro la fine del 2024.
AbbVie (NYSE: ABBV) ha anunciado resultados preliminares positivos de su ensayo clínico de fase 3 TEMPO-1 para tavapadon, un agonista parcial de los receptores de dopamina D1/D5 en investigación, como monoterapia para la enfermedad de Parkinson en etapa temprana. El ensayo alcanzó su objetivo primario, mostrando mejoras estadísticamente significativas en la puntuación combinada de las Partes II y III del MDS-UPDRS a la semana 26 para ambas dosis de 5 mg y 15 mg en comparación con el placebo. También cumplió con un importante objetivo secundario, demostrando una mejora significativa en la puntuación de la Parte II del MDS-UPDRS. El perfil de seguridad fue consistente con ensayos clínicos previos, con la mayoría de los eventos adversos siendo de leves a moderados. Los resultados completos se presentarán en futuras reuniones médicas y se utilizarán para las presentaciones regulatorias. Se espera que los resultados del ensayo de fase 3 TEMPO-2, que estudia tavapadon como monoterapia de dosis flexible, se publiquen a finales de 2024.
AbbVie (NYSE: ABBV)는 초기 파킨슨병에 대한 모노테라피로서 연구 중인 D1/D5 도파민 수용체 부분 작용제인 타바파돈에 대한 3상 TEMPO-1 시험에서 긍정적인 톱라인 결과를 발표했습니다. 이 시험은 주요 목표를 달성했으며, 5mg 및 15mg 용량 모두에서 26주차 MDS-UPDRS Part II와 III의 결합 점수가 위약에 비해 통계적으로 유의미한 개선을 보였습니다. 또한, 핵심 보조 목표를 충족시켜 MDS-UPDRS Part II 점수의 유의미한 개선을 입증했습니다. 안전성 프로필은 이전의 임상 시험과 일치하며, 대부분의 부작용은 경미하거나 중등도로 나타났습니다. 완전한 결과는 향후 의료 회의에서 발표될 예정이며, 규제 제출에 사용될 것입니다. 타바파돈을 유연한 용량의 단일 요법으로 연구하는 3상 TEMPO-2 시험의 결과는 2024년 말까지 나올 것으로 기대됩니다.
AbbVie (NYSE: ABBV) a annoncé des résultats préliminaires positifs de son essai clinique de phase 3 TEMPO-1 pour tavapadon, un agoniste partiel des récepteurs de dopamine D1/D5 en cours d'évaluation, en tant que monothérapie pour la maladie de Parkinson précoce. L'essai a atteint son objectif principal, montrant des améliorations statistiquement significatives dans le score combiné des Parties II et III de l'MDS-UPDRS à la semaine 26 pour les doses de 5 mg et 15 mg par rapport au placebo. Il a également atteint un objectif secondaire clé, démontrant une amélioration significative dans le score de la Partie II de l'MDS-UPDRS. Le profil de sécurité était cohérent avec les études cliniques précédentes, la plupart des événements indésirables étant légers à modérés. Les résultats complets seront soumis pour présentation lors de futures conférences médicales et utilisés pour des soumissions réglementaires. Les résultats de l'essai de phase 3 TEMPO-2, qui étudie le tavapadon en tant que monothérapie à dose flexible, sont attendus d'ici la fin de 2024.
AbbVie (NYSE: ABBV) hat positive vorläufige Ergebnisse aus seiner Phase-3-Studie TEMPO-1 für Tavapadon bekannt gegeben, ein untersuchter partieller Agonist der D1/D5-Dopaminrezeptoren, der als Monotherapie für frühe Parkinson-Erkrankung eingesetzt wird. Die Studie erreichte ihr primäres Ziel und zeigte statistisch signifikante Verbesserungen im kombinierten Punktestand der MDS-UPDRS Teile II und III in Woche 26 für sowohl die 5 mg als auch die 15 mg Dosen im Vergleich zu Placebo. Es erreichte auch ein wichtiges sekundäres Ziel, indem es eine signifikante Verbesserung im Punktestand der MDS-UPDRS Teil II nachwies. Das Sicherheitsprofil war mit vorherigen klinischen Studien konsistent, wobei die meisten unerwünschten Ereignisse mild bis moderat waren. Vollständige Ergebnisse werden für zukünftige medizinische Konferenzen eingereicht und für regulatorische Einreichungen verwendet. Die Ergebnisse der Phase-3-Studie TEMPO-2, die Tavapadon als flexible Dosismonotherapie untersucht, werden bis Ende 2024 erwartet.
- Tavapadon met the primary endpoint in the Phase 3 TEMPO-1 trial, showing statistically significant improvement in MDS-UPDRS Parts II and III combined score
- The trial also met a key secondary endpoint, demonstrating significant improvement in MDS-UPDRS Part II score
- Safety profile was consistent with prior clinical trials, with most adverse events being mild to moderate
- Results support the potential of tavapadon for Parkinson's disease treatment
- None.
Insights
The Phase 3 TEMPO-1 trial results for tavapadon in early Parkinson's disease are highly promising. The study met its primary endpoint, showing statistically significant improvements in MDS-UPDRS Parts II and III combined scores for both 5 mg and 15 mg doses compared to placebo. This indicates meaningful benefits in motor function and activities of daily living.
Key points:
- Primary endpoint:
-9.7% improvement for 5 mg dose and-10.2% for 15 mg dose vs.+1.8% for placebo (p<0.0001) - Secondary endpoint: Significant improvement in MDS-UPDRS Part II (motor aspects of daily living)
- Safety profile consistent with previous trials
These results, combined with the positive TEMPO-3 adjunctive trial data, strengthen tavapadon's potential as a new treatment option for Parkinson's disease. The upcoming TEMPO-2 flexible-dose trial results will be important for a comprehensive efficacy and safety profile.
AbbVie's positive Phase 3 results for tavapadon represent a significant milestone in their neuroscience portfolio expansion strategy. Key financial implications include:
- Potential market expansion: Parkinson's disease affects millions globally, offering a large addressable market
- Diversification: Strengthens AbbVie's position beyond immunology, reducing reliance on Humira revenues
- Competitive advantage: Novel D1/D5 receptor mechanism could differentiate tavapadon in the market
- Near-term catalyst: TEMPO-2 results expected by end of 2024, potentially driving stock momentum
While it's too early to project revenues, successful commercialization could significantly impact AbbVie's long-term growth prospects. Investors should monitor regulatory submission timelines and potential approval dates as key value inflection points.
- Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26
- Trial also met key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score
- Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a flexible-dose monotherapy, are expected by the end of 2024
The TEMPO-1 trial evaluated the efficacy, safety and tolerability of two fixed doses (5 mg and 15 mg, once daily) of tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint – patients treated with tavapadon in both dose groups experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p-value <0.0001 each dose versus placebo) in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.
The TEMPO-1 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 both tavapadon dose groups compared to placebo at week 26.
"The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson's disease," said Primal Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. "This marks a significant step forward in our commitment to enhancing our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition. We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial."
The safety profile observed in the TEMPO-1 trial was consistent with prior clinical trials.1,2 The majority of adverse events reported were mild to moderate in severity.
Full results from the TEMPO-1 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson's disease. Topline results from TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024.
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 a selective D1/D5 receptor partial agonist in development 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 is evaluating 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-1 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of two fixed doses of tavapadon 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 529 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 titrated to 5 milligrams, tavapadon titrated to 15 milligrams or placebo, orally and once-daily.
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
- 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.
- 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
- Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1). National Library of Medicine. Accessed on September 20, 2024. https://clinicaltrials.gov/study/NCT04201093
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