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Tavapadon Meets Primary and Secondary End Points in Phase 3 TEMPO-2 Trial for Early Parkinson Disease
Key Takeaways
- Tavapadon showed significant improvement in motor symptoms and daily living activities in early PD patients, meeting primary and secondary endpoints in the TEMPO-2 trial.
- The trial confirmed tavapadon's safety profile, with most adverse events being mild to moderate, aligning with previous clinical studies.
AbbVie recently announced that it is on track to submit the new drug application for its investigational Parkinson disease agent tavapadon to the FDA in 2025.
Primal Kaur, MD, MBA
(Credit: LinkedIn)
According to a new announcement, topline results from AbbVie’s pivotal phase 3 TEMPO-2 trial assessing investigational tavapadon as a flexible-dose monotherapy revealed that the treatment met its primary and secondary end point among patients with early Parkinson disease (PD). The company noted full results from the trial will be submitted for presentation at a future medical meeting and that it is on track to submit the new drug application to the FDA in 2025.1
Among 304 participants in TEMPO-2, those treated with tavapadon as a monotherapy experienced a statistically significant reduction from baseline compared with placebo in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26 (placebo: -1.2; tavapadon: -10.3; P-value <.0001 versus placebo). In addition, results demonstrated statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in the tavapadon group compared with placebo at 26 weeks.
"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," Primal Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie, said in a statement.1 "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 phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week TEMPO-2 trial investigated the efficacy, safety and tolerability of a flexible-dose treatment with tavapadon as a monotherapy in patients aged between the ages 40 years and 80 years with early PD. All had a confirmed diagnosis of PD and had disease duration, from time of diagnosis, of less than 3 years. In the trial, investigators randomized patients to receive tavapadon 5 mg to 15 mg or placebo, orally and once daily. The primary end point was the change from baseline in the MDS-UPDRS Parts II and III combined score, while key secondary end points included change 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.
READ MORE: Parkinson Agent HL192 Successfully Completes Phase 1 First-In-Human Study
According to Addvie, tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for patients living with PD. The company reported that the safety findings observed in the TEMPO-2 trial were consistent with its known safety profile from previous clinical studies. Overall, the majority of adverse events reported in TEMPO-2 by participants were mild to moderate in severity.
The TEMPO clinical development program investigated the efficacy, safety and tolerability of tavapadon across a broad PD patients population including 2 monotherapy phase 3 trials, TEMPO-1 (NCT04201093) and TEMPO-2, and 1 adjunctive phase 3 trial, TEMPO-3 (NCT04542499). The company noted that it is also performing a fourth, open-label extension (OLE) trial named TEMPO-4 to assess the long-term safety and tolerability of tavapadon in PD.
"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," global principal investigator Hubert H. Fernandez, MD, the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic, said in a statetment.1 "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."
